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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85153

33 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 26, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

33 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 33

BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

Z-1638-2020
Recall number
Z-1638-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 623210, 636020, 822620, 865060, 823110, 922950, 234200, 556590, 801160, 919620, 115650, 401230, 382910, 508910, 189900, 534730, 009800, 280090, 844520, 297620, 554620, 744820, 431230, 913690, 940260, 745380, 981490, 251350, 364310, 675220, 940100, 990100, 327990, 396630, 903720, 295160, 374220, 679700, 679710, 716140, 952890, 496420, 496430, 820430, 816090, 921260, 496440, 496460, 038620, 292650, 441830, 362260, 683620, 966920, 829800, 949730, 591230, 988900, 988910, 826960, 757380, 988910R, 229040, 757370, 757390, 757400, 826970, 893670, 826990, 757410, 826930, 893720, 893710, 808600, 778290, 915190, 808580, 884480, 884490, 920520, 920530, 920540, 920530R, 455880, 455900, 696930, 737370, 737380, 455910, 569270, 569280, 569290, 569300, 569320, 569330, 569340, 569360, 569370, 569380, 696800, 696820, 696830, 696840, 696850, 696860, 696890, 696900, 696910, 765040, 765050, 765060, 765070, 765080, 672450, 672460, 672640, 672650, 672770, 737700, 672480, 696920, 694950, 694960, 671920, 672000. ***UDI Numbers*** (01)00880304521100(17)180220(10)623210, (01)00880304521100(17)180221(10)636020, (01)00880304521100(17)180307(10)822620, (01)00880304521100(17)180308(10)865060, (01)00880304521100(17)180313(10)823110, (01)00880304521100(17)180320(10)922950, (01)00880304521100(17)180503(10)234200, (01)00880304521100(17)180628(10)556590, (01)00880304521100(17)180724(10)801160, (01)00880304521100(17)180808(10)919620, (01)00880304521100(17)180819(10)115650, (01)00880304521100(17)180909(10)401230, (01)00880304521100(17)190101(10)382910, (01)00880304521100(17)190113(10)508910, (01)00880304521100(17)190306(10)189900, (01)00880304521100(17)190426(10)534730, (01)00880304521100(17)190814(10)009800, (01)00880304521100(17)190827(10)280090, (01)00880304521100(17)190827(10)844520, (01)00880304521100(17)190923(10)297620, (01)00880304521100(17)190930(10)554620, (01)00880304521100(17)191024(10)744820, (01)00880304521100(17)191103(10)431230, (01)00880304521100(17)191104(10)913690, (01)00880304521100(17)191029(10)940260, (01)00880304521100(17)191106(10)745380, (01)00880304521100(17)191107(10)981490, (01)00880304521100(17)191203(10)251350, (01)00880304521100(17)191216(10)364310, (01)00880304521100(17)200313(10)675220, (01)00880304521100(17)200318(10)940100, (01)00880304521100(17)200313(10)990100, (01)00880304521100(17)200331(10)327990, (01)00880304521100(17)200420(10)396630, (01)00880304521100(17)200526(10)903720, (01)00880304521100(17)200707(10)295160, (01)00880304521100(17)200707(10)374220, (01)00880304521100(17)200815(10)679700, (01)00880304521100(17)200814(10)679710, (01)00880304521100(17)200820(10)716140, (01)00880304521100(17)200915(10)952890, (01)00880304521100(17)201025(10)496420, (01)00880304521100(17)201022(10)496430, (01)00880304521100(17)201110(10)820430, (01)00880304521100(17)201117(10)816090, (01)00880304521100(17)201119(10)921260, (01)00880304521100(17)201202(10)496440, (01)00880304521100(17)201202(10)496460, (01)00880304521100(17)201215(10)038620, (01)00880304521100(17)210112(10)292650, (01)00880304521100(17)210120(10)441830, (01)00880304521100(17)210201(10)362260, (01)00880304521100(17)210209(10)683620, (01)00880304521100(17)210317(10)966920, (01)00880304521100(17)210524(10)829800, (01)00880304521100(17)210604(10)949730, (01)00880304521100(17)210728(10)591230, (01)00880304521100(17)220429(10)988900, (01)00880304521100(17)220429(10)988910, (01)00880304521100(17)220620(10)826960, (01)00880304521100(17)220622(10)757380, (01)00880304521100(17)220429(10)988910R, (01)00880304521100(17)220727(10)229040, (01)00880304521100(17)221022(10)757370, (01)00880304521100(17)221021(10)757390, (01)00880304521100(17)221021(10)757400, (01)00880304521100(17)221024(10)826970, (01)00880304521100(17)221021(10)893670, (01)00880304521100(17)221026(10)826990, (01)00880304521100(17)221025(10)757410, (01)00880304521100(17)221103(10)826930, (01)00880304521100(17)221026(10)893720, (01)00880304521100(17)221228(10)893710, (01)00880304521100(17)230117(10)808600, (01)00880304521100(17)230124(10)778290, (01)00880304521100(17)230228(10)915190, (01)00880304521100(17)230410(10)808580, (01)00880304521100(17)230410(10)884480, (01)00880304521100(17)230412(10)884490, (01)00880304521100(17)230507(10)920520, (01)00880304521100(17)230510(10)920530, (01)00880304521100(17)230510(10)920540, (01)00880304521100(17)230510(10)920530R, (01)00880304521100(17)240513(10)455880, (01)00880304521100(17)240513(10)455900, (01)00880304521100(17)240611(10)696930, (01)00880304521100(17)240612(10)455910, (01)00880304521100(17)240622(10)569270, (01)00880304521100(17)240529(10)569280, (01)00880304521100(17)240620(10)569290, (01)00880304521100(17)240617(10)569300, (01)00880304521100(17)240617(10)569320, (01)00880304521100(17)240619(10)569330, (01)00880304521100(17)240615(10)569340, (01)00880304521100(17)240615(10)569360, (01)00880304521100(17)240621(10)569370, (01)00880304521100(17)240621(10)569380, (01)00880304521100(17)240611(10)696800, (01)00880304521100(17)240620(10)696820, (01)00880304521100(17)240619(10)696830, (01)00880304521100(17)240612(10)696840, (01)00880304521100(17)240618(10)696850, (01)00880304521100(17)240801(10)696860, (01)00880304521100(17)240617(10)696890, (01)00880304521100(17)240620(10)696900, (01)00880304521100(17)240621(10)696910, (01)00880304521100(17)240622(10)765040, (01)00880304521100(17)240617(10)765050, (01)00880304521100(17)240617(10)765060, (01)00880304521100(17)240617(10)765070, (01)00880304521100(17)240622(10)765080, (01)00880304521100(17)240817(10)672450, (01)00880304521100(17)240816(10)672460, (01)00880304521100(17)240816(10)672640, (01)00880304521100(17)240817(10)672650, (01)00880304521100(17)240817(10)672770, (01)00880304521100(17)240816(10)737700, (01)00880304521100(17)240913(10)672480, (01)00880304521100(17)240918(10)696920, (01)00880304521100(17)240926(10)694950, (01)00880304521100(17)240926(10)694960, (01)00880304521100(17)241003(10)671920, (01)00880304521100(17)241003(10)672000

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 2 of 33

BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

Z-1639-2020
Recall number
Z-1639-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 572290, 961940, 769090, 961950, 982370, 321690, 623220, 636030, 853960, 050730, 050740, 082030, 020960, 201900, 234210, 392780, 556600, 846260, 171620, 401240, 382920, 090430, 474060, 353200, 419290, 474070, 271550, 280100, 009830, 758570, 009810, 063980, 431240, 913700, 940270, 251360, 470170, 990110, 229340, 858190, 790240, 790250, 295180, 679730, 679720, 048450, 952900, 853130, 931890, 931900, 716130, 496490, 152510, 313800, 390440, 496470, 496510, 937100, 972200, 362290, 362270, 362280, 528960, 676860, 676890, 676960, 677030, 966930, 966940, 184470, 829810, 949750, 949760, 184460, 591250, 591240, 988930, 988940, 558090, 251360R, 827050, 827030, 827070, 892630, 892670, 893780, 893810, 893820, 892680, 893800, 229540, 778270, 893750, 628530, 628540, 778280, 628550, 618570, 618580, 618590, 884510, 747430, 827850, 884520, 827010, 893800R, 455690, 455770, 455780, 455760, 478940, 478900, 569610, 570060, 477280, 478790, 455720, 455730, 476940, 477030, 477080, 477100, 477120, 477130, 477220, 478810, 478880, 478890, 478920, 478930, 568920, 568950, 568960, 568970, 568980, 569000, 569030, 569050, 569540, 569560, 569570, 569590, 569640, 569700, 569780, 569820, 569850, 570000, 570030, 570070, 570090, 570110, 569260, 672780, 737430, 737440, 737460, 226440, 226460, 226470, 478860, 694970, 672020, 672030, 672010, 737540. ***UDI Numbers*** (01)00880304521032(17)170428(10)572290, (01)00880304521032(17)171206(10)961940, (01)00880304521032(17)171207(10)769090, (01)00880304521032(17)171212(10)961950, (01)00880304521032(17)171221(10)982370, (01)00880304521032(17)180116(10)321690, (01)00880304521032(17)180228(10)623220, (01)00880304521032(17)180319(10)636030, (01)00880304521032(17)180319(10)853960, (01)00880304521032(17)180404(10)050730, (01)00880304521032(17)180405(10)050740, (01)00880304521032(17)180405(10)082030, (01)00880304521032(17)180410(10)020960, (01)00880304521032(17)180507(10)201900, (01)00880304521032(17)180506(10)234210, (01)00880304521032(17)180520(10)392780, (01)00880304521032(17)180625(10)556600, (01)00880304521032(17)180723(10)846260, (01)00880304521032(17)180819(10)171620, (01)00880304521032(17)181014(10)401240, (01)00880304521032(17)190113(10)382920, (01)00880304521032(17)190306(10)090430, (01)00880304521032(17)190416(10)474060, (01)00880304521032(17)190502(10)353200, (01)00880304521032(17)190501(10)419290, (01)00880304521032(17)190505(10)474070, (01)00880304521032(17)190626(10)271550, (01)00880304521032(17)190731(10)280100, (01)00880304521032(17)190815(10)009830, (01)00880304521032(17)190815(10)758570, (01)00880304521032(17)190827(10)009810, (01)00880304521032(17)190828(10)063980, (01)00880304521032(17)190924(10)431240, (01)00880304521032(17)191024(10)913700, (01)00880304521032(17)191103(10)940270, (01)00880304521032(17)191125(10)251360, (01)00880304521032(17)191212(10)470170, (01)00880304521032(17)200227(10)990110, (01)00880304521032(17)200304(10)229340, (01)00880304521032(17)200315(10)858190, (01)00880304521032(17)200515(10)790240, (01)00880304521032(17)200527(10)790250, (01)00880304521032(17)200707(10)295180, (01)00880304521032(17)200811(10)679730, (01)00880304521032(17)200814(10)679720, (01)00880304521032(17)200908(10)048450, (01)00880304521032(17)200909(10)952900, (01)00880304521032(17)200910(10)853130, (01)00880304521032(17)200914(10)931890, (01)00880304521032(17)200911(10)931900, (01)00880304521032(17)201009(10)716130, (01)00880304521032(17)201218(10)496490, (01)00880304521032(17)210107(10)152510, (01)00880304521032(17)210111(10)313800, (01)00880304521032(17)210107(10)390440, (01)00880304521032(17)210107(10)496470, (01)00880304521032(17)210107(10)496510, (01)00880304521032(17)210107(10)937100, (01)00880304521032(17)210107(10)972200, (01)00880304521032(17)210201(10)362290, (01)00880304521032(17)210227(10)362270, (01)00880304521032(17)210228(10)362280, (01)00880304521032(17)210308(10)528960, (01)00880304521032(17)210310(10)676860, (01)00880304521032(17)210316(10)676890, (01)00880304521032(17)210311(10)676960, (01)00880304521032(17)210311(10)677030, (01)00880304521032(17)210317(10)966930, (01)00880304521032(17)210317(10)966940, (01)00880304521032(17)210606(10)184470, (01)00880304521032(17)210603(10)829810, (01)00880304521032(17)210606(10)949750, (01)00880304521032(17)210603(10)949760, (01)00880304521032(17)210701(10)184460, (01)00880304521032(17)210808(10)591250, (01)00880304521032(17)210816(10)591240, (01)00880304521032(17)210915(10)988930, (01)00880304521032(17)210919(10)988940, (01)00880304521032(17)220610(10)558090, (01)00880304521032(17)191125(10)251360R, (01)00880304521032(17)220626(10)827050, (01)00880304521032(17)220930(10)827030, (01)00880304521032(17)221003(10)827070, (01)00880304521032(17)220929(10)892630, (01)00880304521032(17)220929(10)892670, (01)00880304521032(17)220929(10)893780, (01)00880304521032(17)221003(10)893810, (01)00880304521032(17)220929(10)893820, (01)00880304521032(17)221009(10)892680, (01)00880304521032(17)221012(10)893800, (01)00880304521032(17)221018(10)229540, (01)00880304521032(17)221019(10)778270, (01)00880304521032(17)221018(10)893750, (01)00880304521032(17)221116(10)628530, (01)00880304521032(17)221118(10)628540, (01)00880304521032(17)221121(10)778280, (01)00880304521032(17)221130(10)628550, (01)00880304521032(17)230330(10)618570, (01)00880304521032(17)230402(10)618580, (01)00880304521032(17)230402(10)618590, (01)00880304521032(17)230402(10)884510, (01)00880304521032(17)230405(10)747430, (01)00880304521032(17)230408(10)827850, (01)00880304521032(17)230408(10)884520, (01)00880304521032(17)220731(10)827010, (01)00880304521032(17)221012(10)893800R, (01)00880304521032(17)240510(10)455690, (01)00880304521032(17)240513(10)455770, (01)00880304521032(17)240510(10)455780, (01)00880304521032(17)240517(10)455760, (01)00880304521032(17)240517(10)478940, (01)00880304521032(17)240526(10)478900, (01)00880304521032(17)240525(10)569610, (01)00880304521032(17)240525(10)570060, (01)00880304521032(17)240608(10)477280, (01)00880304521032(17)240608(10)478790, (01)00880304521032(17)240510(10)455720, (01)00880304521032(17)240619(10)455730, (01)00880304521032(17)240528(10)476940, (01)00880304521032(17)240617(10)477030, (01)00880304521032(17)240621(10)477080, (01)00880304521032(17)240619(10)477100, (01)00880304521032(17)240622(10)477120, (01)00880304521032(17)240617(10)477130, (01)00880304521032(17)240621(10)477220, (01)00880304521032(17)240622(10)478810, (01)00880304521032(17)240620(10)478880, (01)00880304521032(17)240528(10)478890, (01)00880304521032(17)240802(10)478920, (01)00880304521032(17)240528(10)478930, (01)00880304521032(17)240621(10)568920, (01)00880304521032(17)240620(10)568950, (01)00880304521032(17)240802(10)568960, (01)00880304521032(17)240622(10)568970, (01)00880304521032(17)240715(10)568980, (01)00880304521032(17)240622(10)569000, (01)00880304521032(17)240622(10)569030, (01)00880304521032(17)240529(10)569050, (01)00880304521032(17)240622(10)569540, (01)00880304521032(17)240801(10)569560, (01)00880304521032(17)240620(10)569570, (01)00880304521032(17)240623(10)569590, (01)00880304521032(17)240609(10)569640, (01)00880304521032(17)240529(10)569700, (01)00880304521032(17)240529(10)569780, 01)00880304521032(17)240611(10)569820, (01)00880304521032(17)240529(10)569850, (01)00880304521032(17)240530(10)570000, (01)00880304521032(17)240617(10)570030, (01)00880304521032(17)240620(10)570070, (01)00880304521032(17)240617(10)570090, (01)00880304521032(17)240629(10)570110, (01)00880304521032(17)240816(10)569260, (01)00880304521032(17)240815(10)672780, (01)00880304521032(17)240817(10)737430, (01)00880304521032(17)240817(10)737440, (01)00880304521032(17)240817(10)737460, (01)00880304521032(17)240817(10)737480, (01)00880304521032(17)240926(10)226440, (01)00880304521032(17)240926(10)226460, (01)00880304521032(17)240925(10)226470, (01)00880304521032(17)240927(10)478860, (01)00880304521032(17)240925(10)694970, (01)00880304521032(17)241003(10)672020, (01)00880304521032(17)241003(10)672030, (01)00880304521032(17)241009(10)672010, (01)00880304521032(17)250111(10)737540

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 3 of 33

BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

Z-1640-2020
Recall number
Z-1640-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 082090, 651800, 982380, 809020, 320900, 623230, 623240, 630160, 636040, 823140, 234220, 370430, 556610, 047420, 846270, 270160, 374980, 382930, 508920, 419300, 189910, 404850, 844540, 474080, 009850, 467650, 297630, 280110, 913710, 913720, 916350, 039560, 364320, 858200, 557640, 990120, 328020, 102150, 486050, 903730, 295200, 906770, 906940, 907000, 109280, 952910, 627830, 496520, 972210, 038630, 112390, 496530, 627840, 292590, 401300, 441840, 362300, 683630, 966950, 074190, 184490, 829820, 949770, 591260, 988950, 322780, 757440, 827110, 827090, 229610, 404850R, 892790, 673830, 229600, 827060, 757460, 892730, 892750, 757430, 757450, 827080, 628570, 808650, 628560, 808640, 884540, 884530, 757420, 757490, 765160, 456220, 456250, 456260, 456280, 456300, 456350, 456190, 456370, 483850, 483950, 638590, 638640, 478960, 478970, 478990, 479020, 479040, 483830, 483860, 483880, 483900, 483920, 483940, 483960, 483970, 483990, 569060, 569080, 569090, 569110, 569130, 569140, 569160, 569210, 569240, 570120, 570130, 638550, 638560, 638580, 638600, 638620, 638630, 638650, 638670, 638680, 638690, 638700, 638710, 765090, 765110, 765120, 765150, 765180, 765190, 765210, 765230, 765240, 765260, 765270, 569100, 988390, 483910, 638540, 979260, 981280, 989340, 988640 989850, ***UDI Numbers*** (01)00880304521254(17)170728(10)082090, (01)00880304521254(17)171228(10)651800, (01)00880304521254(17)171221(10)982380, (01)00880304521254(17)171226(10)809020, (01)00880304521254(17)180118(10)320900, (01)00880304521254(17)180213(10)623230, (01)00880304521254(17)180215(10)623240, (01)00880304521254(17)180221(10)630160, (01)00880304521254(17)180220(10)636040, (01)00880304521254(17)180307(10)823140, (01)00880304521254(17)180430(10)234220, (01)00880304521254(17)180603(10)370430, (01)00880304521254(17)180620(10)556610, (01)00880304521254(17)180809(10)047420, (01)00880304521254(17)180811(10)846270, (01)00880304521254(17)180903(10)270160, (01)00880304521254(17)180927(10)374980, (01)00880304521254(17)190102(10)382930, (01)00880304521254(17)190113(10)508920, (01)00880304521254(17)190220(10)419300, (01)00880304521254(17)190404(10)189910, (01)00880304521254(17)190416(10)404850, (01)00880304521254(17)190513(10)844540, (01)00880304521254(17)190603(10)474080, (01)00880304521254(17)190820(10)009850, (01)00880304521254(17)190827(10)467650, (01)00880304521254(17)190916(10)297630, (01)00880304521254(17)191008(10)280110, (01)00880304521254(17)191024(10)913710, (01)00880304521254(17)191025(10)913720, (01)00880304521254(17)191104(10)916350, (01)00880304521254(17)191110(10)039560, (01)00880304521254(17)191223(10)364320, (01)00880304521254(17)200302(10)858200, (01)00880304521254(17)200313(10)557640, (01)00880304521254(17)200315(10)990120, (01)00880304521254(17)200324(10)328020, (01)00880304521254(17)200401(10)102150, (01)00880304521254(17)200416(10)486050, (01)00880304521254(17)200527(10)903730, (01)00880304521254(17)200707(10)295200, (01)00880304521254(17)200824(10)906770, (01)00880304521254(17)200825(10)906940, (01)00880304521254(17)200821(10)907000, (01)00880304521254(17)200915(10)109280, (01)00880304521254(17)200924(10)952910, (01)00880304521254(17)201117(10)627830, (01)00880304521254(17)201202(10)496520, (01)00880304521254(17)201207(10)972210, (01)00880304521254(17)201215(10)038630, (01)00880304521254(17)201214(10)112390, (01)00880304521254(17)201214(10)496530, (01)00880304521254(17)201215(10)627840, (01)00880304521254(17)201230(10)292590, (01)00880304521254(17)210112(10)401300, (01)00880304521254(17)210118(10)441840, (01)00880304521254(17)210202(10)362300, (01)00880304521254(17)210210(10)362310, (01)00880304521254(17)210216(10)727010, (01)00880304521254(17)210302(10)683630, (01)00880304521254(17)210303(10)966950, (01)00880304521254(17)210318(10)074190, (01)00880304521254(17)210322(10)184490, (01)00880304521254(17)210527(10)829820, (01)00880304521254(17)210601(10)949770, (01)00880304521254(17)210824(10)591260, (01)00880304521254(17)220104(10)988950, (01)00880304521254(17)220429(10)322780, (01)00880304521254(17)220620(10)757440, (01)00880304521254(17)220620(10)827110, (01)00880304521254(17)220630(10)827090, (01)00880304521254(17)220725(10)229610, (01)00880304521254(17)190416(10)404850R, (01)00880304521254(17)221102(10)892790, (01)00880304521254(17)221116(10)673830, (01)00880304521254(17)221117(10)229600, (01)00880304521254(17)221117(10)827060, (01)00880304521254(17)221121(10)757460, (01)00880304521254(17)221129(10)892730, (01)00880304521254(17)221130(10)892750, (01)00880304521254(17)221211(10)757430, (01)00880304521254(17)221215(10)757450, (01)00880304521254(17)221103(10)827080, (01)00880304521254(17)230209(10)628570, (01)00880304521254(17)230209(10)808650, (01)00880304521254(17)230217(10)628560, (01)00880304521254(17)230227(10)808640, (01)00880304521254(17)230308(10)884540, (01)00880304521254(17)230416(10)884530, (01)00880304521254(17)221113(10)757420, (01)00880304521254(17)221113(10)757490, (01)00880304521254(17)240815(10)765160, (01)00880304521254(17)240512(10)456220, (01)00880304521254(17)240513(10)456250, (01)00880304521254(17)240513(10)456260, (01)00880304521254(17)240512(10)456280, (01)00880304521254(17)240512(10)456300, (01)00880304521254(17)240513(10)456350, (01)00880304521254(17)240517(10)456190, (01)00880304521254(17)240517(10)456370, (01)00880304521254(17)240525(10)483850, (01)00880304521254(17)240528(10)483950, (01)00880304521254(17)240525(10)638590, (01)00880304521254(17)240608(10)638640, (01)00880304521254(17)240627(10)478960, (01)00880304521254(17)240628(10)478970, (01)00880304521254(17)240628(10)478990, (01)00880304521254(17)240629(10)479020, (01)00880304521254(17)240614(10)479040, (01)00880304521254(17)240627(10)483830, (01)00880304521254(17)240629(10)483860, (01)00880304521254(17)240622(10)483880, (01)00880304521254(17)240630(10)483900, (01)00880304521254(17)240628(10)483920, (01)00880304521254(17)240709(10)483940, (01)00880304521254(17)240628(10)483960, (01)00880304521254(17)240709(10)483970, (01)00880304521254(17)240709(10)483990, (01)00880304521254(17)240710(10)569060, (01)00880304521254(17)240710(10)569080, (01)00880304521254(17)240710(10)569090, (01)00880304521254(17)240627(10)569110, (01)00880304521254(17)240710(10)569130, (01)00880304521254(17)240617(10)569140, (01)00880304521254(17)240630(10)569160, (01)00880304521254(17)240702(10)569210, (01)00880304521254(17)240710(10)569240, (01)00880304521254(17)240627(10)570120, (01)00880304521254(17)240709(10)570130, (01)00880304521254(17)240611(10)638550, (01)00880304521254(17)240711(10)638560, (01)00880304521254(17)240710(10)638580, (01)00880304521254(17)240610(10)638600, (01)00880304521254(17)240629(10)638620, (01)00880304521254(17)240709(10)638630, (01)00880304521254(17)240708(10)638650, (01)00880304521254(17)240608(10)638670, (01)00880304521254(17)240623(10)638680, (01)00880304521254(17)240609(10)638690, (01)00880304521254(17)240620(10)638700, (01)00880304521254(17)240610(10)638710, (01)00880304521254(17)240710(10)765090, (01)00880304521254(17)240628(10)765110, (01)00880304521254(17)240708(10)765120, (01)00880304521254(17)240710(10)765150, (01)00880304521254(17)240710(10)765180, (01)00880304521254(17)240709(10)765190, (01)00880304521254(17)240627(10)765210, (01)00880304521254(17)240621(10)765230, (01)00880304521254(17)240629(10)765240, (01)00880304521254(17)240628(10)765260, (01)00880304521254(17)240710(10)765270, (01)00880304521254(17)240829(10)569100, (01)00880304521254(17)240828(10)988390, (01)00880304521254(17)240916(10)483910, (01)00880304521254(17)240914(10)638540, (01)00880304521254(17)240925(10)979260, (01)00880304521254(17)240925(10)981280, (01)00880304521254(17)240926(10)989340, (01)00880304521254(17)241009(10)988640, (01)00880304521254(17)241011(10)989850

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 4 of 33

BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

Z-1641-2020
Recall number
Z-1641-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230, 001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 104420, 982400, 982410, 321650, 321010, 623250, 922960, 031220, 997610, 556620, 122900, 382940, 419310, 474090, 758580, 009860, 913730, 188870, 640320, 790260, 132370, 820480, 931920, 952920, 627850, 816100, 990340, 152520, 334530, 362320, 362330, 966960, 829830, 322800, 322790, 322810, 322810R, 827140, 362330R, 229620, 757600, 808680, 118530, 118540, 972010, 757500, 757510, 808690, 827120, 827150, 118520, 118560, 884560, 827900, 827870, 431600, 884550, 455990, 479080, 569440, 479070, 479090, 479100, 569390, 569400, 569410, 569420, 569450, 569490, 827120R, 884550R, 455980, 985690, 986830, 990920, 990000, 987900, 990680, 978380. ***UDI Numbers*** (01)00880304521056(17)160928(10)104420, (01)00880304521056(17)171228(10)982400, (01)00880304521056(17)171221(10)982410, (01)00880304521056(17)180122(10)321650, (01)00880304521056(17)180208(10)321010, (01)00880304521056(17)180308(10)623250, (01)00880304521056(17)180313(10)922960, (01)00880304521056(17)180329(10)031220, (01)00880304521056(17)180329(10)997610, (01)00880304521056(17)180617(10)556620, (01)00880304521056(17)180819(10)122900, (01)00880304521056(17)190106(10)382940, (01)00880304521056(17)190113(10)419310, (01)00880304521056(17)190425(10)474090, (01)00880304521056(17)190425(10)758580, (01)00880304521056(17)190819(10)009860, (01)00880304521056(17)191024(10)913730, (01)00880304521056(17)191125(10)188870, (01)00880304521056(17)200124(10)640320, (01)00880304521056(17)200512(10)790260, (01)00880304521056(17)200610(10)132370, (01)00880304521056(17)200813(10)820480, (01)00880304521056(17)200827(10)931920, (01)00880304521056(17)200903(10)952920, (01)00880304521056(17)201106(10)627850, (01)00880304521056(17)201110(10)816100, (01)00880304521056(17)201204(10)990340, (01)00880304521056(17)210112(10)152520, (01)00880304521056(17)210111(10)334530, (01)00880304521056(17)210209(10)362320, (01)00880304521056(17)210209(10)362330, (01)00880304521056(17)210303(10)966960, (01)00880304521056(17)210524(10)829830, (01)00880304521056(17)210921(10)322800, (01)00880304521056(17)210927(10)322790, (01)00880304521056(17)220107(10)322810, (01)00880304521056(17)220107(10)322810R, (01)00880304521056(17)220621(10)827140, (01)00880304521056(17)210209(10)362330R, (01)00880304521056(17)220726(10)229620, (01)00880304521056(17)230120(10)757600, (01)00880304521056(17)230124(10)808680, (01)00880304521056(17)230209(10)118530, (01)00880304521056(17)230209(10)118540, (01)00880304521056(17)230209(10)972010, (01)00880304521056(17)230216(10)757500, (01)00880304521056(17)230216(10)757510, (01)00880304521056(17)230217(10)808690, (01)00880304521056(17)230219(10)827120, (01)00880304521056(17)230217(10)827150, (01)00880304521056(17)230302(10)118520, (01)00880304521056(17)230302(10)118560, (01)00880304521056(17)230301(10)884560, (01)00880304521056(17)230308(10)827900, (01)00880304521056(17)230417(10)827870, (01)00880304521056(17)230425(10)431600, (01)00880304521056(17)230425(10)884550, (01)00880304521056(17)240513(10)455990, (01)00880304521056(17)240517(10)479080, (01)00880304521056(17)240608(10)569440, (01)00880304521056(17)240614(10)479070, (01)00880304521056(17)240615(10)479090, (01)00880304521056(17)240620(10)479100, (01)00880304521056(17)240610(10)569390, (01)00880304521056(17)240614(10)569400, (01)00880304521056(17)240612(10)569410, (01)00880304521056(17)240609(10)569420, (01)00880304521056(17)240614(10)569450, (01)00880304521056(17)240614(10)569490, (01)00880304521056(17)230219(10)827120R, (01)00880304521056(17)230425(10)884550R, (01)00880304521056(17)240830(10)455980, (01)00880304521056(17)240925(10)985690, (01)00880304521056(17)240926(10)986830, (01)00880304521056(17)240925(10)990920, (01)00880304521056(17)241003(10)990000, (01)00880304521056(17)241011(10)987900, (01)00880304521056(17)241024(10)990680, (01)00880304521056(17)250102(10)978380

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 5 of 33

BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

Z-1642-2020
Recall number
Z-1642-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230, 001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210,***UDI Numbers*** (01)00880304521063(17)151228(10)004800, (01)00880304521063(17)160728(10)104440, (01)00880304521063(17)170228(10)734050, (01)00880304521063(17)170728(10)082110, (01)00880304521063(17)170928(10)912150, (01)00880304521063(17)171207(10)961960, (01)00880304521063(17)180106(10)092470, (01)00880304521063(17)180219(10)630170, (01)00880304521063(17)180620(10)602290, (01)00880304521063(17)180904(10)357210, (01)00880304521063(17)190113(10)508930, (01)00880304521063(17)190505(10)474100, (01)00880304521063(17)191025(10)913740, (01)00880304521063(17)191215(10)364330, (01)00880304521063(17)200416(10)396650, (01)00880304521063(17)200706(10)295210, (01)00880304521063(17)200825(10)854280, (01)00880304521063(17)200825(10)952930, (01)00880304521063(17)201119(10)816110, (01)00880304521063(17)210126(10)362340, (01)00880304521063(17)210317(10)184510, (01)00880304521063(17)210919(10)988980, (01)00880304521063(17)220115(10)988960, (01)00880304521063(17)220620(10)827160, (01)00880304521063(17)210126(10)362340R, (01)00880304521063(17)220727(10)231990, (01)00880304521063(17)220726(10)232110, (01)00880304521063(17)221229(10)757770, (01)00880304521063(17)230116(10)757640, (01)00880304521063(17)230115(10)827170, (01)00880304521063(17)230123(10)757740, (01)00880304521063(17)230216(10)757700, (01)00880304521063(17)230417(10)118590, (01)00880304521063(17)230424(10)118580, (01)00880304521063(17)230424(10)884570, (01)00880304521063(17)191025(10)913740R, (01)00880304521063(17)240513(10)455920, (01)00880304521063(17)240528(10)569510, (01)00880304521063(17)200416(10)396650R, (01)00880304521063(17)240829(10)740650, (01)00880304521063(17)240829(10)800090, (01)00880304521063(17)240829(10)911390, (01)00880304521063(17)240828(10)926010, (01)00880304521063(17)230424(10)118580R, (01)00880304521063(17)240915(10)911440, (01)00880304521063(17)240913(10)911480, (01)00880304521063(17)240915(10)925990, (01)00880304521063(17)240913(10)926000, (01)00880304521063(17)240915(10)926040, (01)00880304521063(17)240925(10)868260, (01)00880304521063(17)240927(10)911470, (01)00880304521063(17)240926(10)926050, (01)00880304521063(17)241010(10)464210, (01)00880304521063(17)241001(10)926030 926030.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 6 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

Z-1643-2020
Recall number
Z-1643-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 502050, 628160, 754710, 795480, 383860, 938730, 258280, 258190, 520980, 794470, 135080, 407080, 474100, 333620, 576720, 739510, 789340, 949520, 062820, 233420, 348160, 341200, 554920, 750800, 914960, 914980, 117230, 127860, 167340, 551760, 135720, 135760, 135770, 584700, 266500, 266520, 817710, 817680, 462720, 549240, 549340, 462600, 588980, 962650, 048960, 052030, 462420, 462470, 462500, 846510, 846550, 846660, 061800, 353690, 353770, 353730, 353790, 739210, 816110, 816220, 374890, 374880, 654990, 655000, 655010, 792120, 803200, 733600, 792110, 980400, 092160, 118970, 205620, 364700, 756370, 760140, 771060, 771070, 771080, 745790, 770910, 770920, 045110, 063710, 332900, 774490, 774480, 966970, 966990, 017840, 017580, 152210, 912450, 624130, 624140, 665090, 396720, 396730, 418450, 418460, 777400, 777430, 996050, 996060, 996070, 353770R, 092160R, 374890R, 654990R, 418460R, 810910, 864940, 864970, 777670, 906710, 996060R, 115970, 864960, 116000, 116020, 232620, 201250, 201280, 232550, 545970, 996050R, 232590, 232610, 201270, 201300, 269250, 269270, 269280, 269290, 269300, 269320, 269260, 269310, 201290, 401150, 401170, 401200, 888220, 875400, 988830, 034500, 848610, 256590, 377770, 495000, 275070, 377780, 766090, 942270, 942440, 916800, 916830, 942280, 942430, 777670R, 477940, 478080, 478180, 478200, 518250, 518260, 518290, 478150, 518240, 518280, 518310, 276800, 355820, 661780, 661790, 661800, 661880, 661740, 661860, 765320, 812830, 403850, 404010, 404050, 445450, 505080, 661750, 661760, 661840, 661850, 661890, 661900, 765300, 812840, 813460, 813480, 813700, 813710, 813720, 841860, 864630, 864710, 864760, 879790, 037330, 084060, 374880R, 803200R, 037530, 084040, 084050, 172140, 152380, 528120, 580040, 751390, 751400, 751430, 777220, 807610, 807650, 751410, 777210, 807600, 864670, 883840, 883860, 894050, 894060, 894080, 250560, 894100, 330940, 770920R, 465340, 465350, 465360, 488010, 488020, 503360, 605630, 605650, 605660, 641580, 641550, 723430, 723460, 723470, 276800R, 771080R, 812830R, 865620, 723440, 723450, 770210, 810920, 834760, 865610, 865630, 865640, 885100, 885150, 885170, 885200, 792640, 885110, 885120, 885130, 865650, 909870, 478210, 002300, 034890, 865660, 910000. ***UDI Numbers*** (01)00880304521995(17)160828(10)502050, (01)00880304521995(17)160928(10)628160, (01)00880304521995(17)170328(10)754710, (01)00880304521995(17)170328(10)795480, (01)00880304521995(17)170428(10)383860, (01)00880304521995(17)170928(10)938730, (01)00880304521995(17)171028(10)258280, (01)00880304521995(17)171028(10)258190, (01)00880304521995(17)171028(10)520980, (01)00880304521995(17)171128(10)794470, (01)00880304521995(17)171228(10)135080, (01)00880304521995(17)180117(10)407080, (01)00880304521995(17)180201(10)474100, (01)00880304521995(17)180212(10)333620, (01)00880304521995(17)180215(10)576720, (01)00880304521995(17)180307(10)739510, (01)00880304521995(17)180307(10)789340, (01)00880304521995(17)180401(10)949520, 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(01)00880304521995(17)190926(10)588980, (01)00880304521995(17)191023(10)962650, (01)00880304521995(17)191103(10)048960, (01)00880304521995(17)191112(10)052030, (01)00880304521995(17)191215(10)462420, (01)00880304521995(17)191230(10)462470, (01)00880304521995(17)191215(10)462500, (01)00880304521995(17)200131(10)846510, (01)00880304521995(17)200131(10)846550, (01)00880304521995(17)200131(10)846660, (01)00880304521995(17)200314(10)061800, (01)00880304521995(17)200402(10)353690, (01)00880304521995(17)200403(10)353770, (01)00880304521995(17)200401(10)353730, (01)00880304521995(17)200408(10)353790, (01)00880304521995(17)200519(10)739210, (01)00880304521995(17)200514(10)816110, (01)00880304521995(17)200519(10)816220, (01)00880304521995(17)200707(10)374890, (01)00880304521995(17)200713(10)374880, (01)00880304521995(17)200806(10)654990, (01)00880304521995(17)200812(10)655000, (01)00880304521995(17)200805(10)655010, (01)00880304521995(17)200817(10)792120, (01)00880304521995(17)200813(10)803200, (01)00880304521995(17)200821(10)733600, (01)00880304521995(17)200820(10)792110, (01)00880304521995(17)200914(10)980400, (01)00880304521995(17)200918(10)092160, (01)00880304521995(17)200917(10)118970, (01)00880304521995(17)201015(10)205620, (01)00880304521995(17)201015(10)364700, (01)00880304521995(17)201105(10)756370, (01)00880304521995(17)201110(10)760140, (01)00880304521995(17)201116(10)771060, (01)00880304521995(17)201117(10)771070, (01)00880304521995(17)201117(10)771080, (01)00880304521995(17)201119(10)745790, (01)00880304521995(17)201120(10)770910, (01)00880304521995(17)201120(10)770920, (01)00880304521995(17)201202(10)045110, (01)00880304521995(17)210112(10)063710, (01)00880304521995(17)210212(10)332900, (01)00880304521995(17)210215(10)774490, (01)00880304521995(17)210217(10)774480, (01)00880304521995(17)210224(10)966970, (01)00880304521995(17)210224(10)966990, (01)00880304521995(17)210308(10)017840, (01)00880304521995(17)210309(10)017580, (01)00880304521995(17)210325(10)152210, 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(01)00880304521995(17)220410(10)996060R, (01)00880304521995(17)220722(10)115970, (01)00880304521995(17)220627(10)864960, (01)00880304521995(17)220723(10)116000, (01)00880304521995(17)220723(10)116020, (01)00880304521995(17)220823(10)232620, (01)00880304521995(17)221003(10)201250, (01)00880304521995(17)221002(10)201280, (01)00880304521995(17)220929(10)232550, (01)00880304521995(17)220929(10)545970, (01)00880304521995(17)220409(10)996050R, (01)00880304521995(17)221003(10)232590, (01)00880304521995(17)221005(10)232610, (01)00880304521995(17)221012(10)201270, (01)00880304521995(17)221020(10)201300, (01)00880304521995(17)221023(10)269250, (01)00880304521995(17)221018(10)269270, (01)00880304521995(17)221019(10)269280, (01)00880304521995(17)221103(10)269290, (01)00880304521995(17)221101(10)269300, (01)00880304521995(17)221103(10)269320, (01)00880304521995(17)221111(10)269260, (01)00880304521995(17)221109(10)269310, (01)00880304521995(17)230116(10)201290, 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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 7 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

Z-1644-2020
Recall number
Z-1644-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500, 453510, 546840, 546880, 547080, 940920, 437500, 437530, 477540, 546870, 974080, 105570, 226490, 547090, 071960, 105390, 799100R, 071940, 105470, 105550, 105460, 105480, 105510, 105520, 105430, 295490, 295500, 431310, 712100, 808020, 950370, 808030, 295470, 988850, 143520, 497700, 916880, 917200, 431520, 437530R, 478430, 478260, 478280, 478300, 478330, 478370, 478450, 518400, 518410, 518450, 518460, 478220, 570450, 639600, 639620, 639660, 639680, 639690, 644470, 661920, 661930, 661950, 662000, 261760, 261790, 276830, 661960, 661970, 661980, 662020, 518350, 661940, 696960, 696990, 455030, 570430, 639630, 661910, 696970, 697000, 697010, 697030, 813490, 813500, 845200, 845240, 845250, 845260, 845280, 845290, 845320, 845340, 845360, 877430, 877440, 877480, 877490, 877500, 063780, 084080, 037540, 063760, 171950, 210360, 210520, 210620, 772760, 777240, 788240, 806930, 838060, 894140, 028960, 900530, 330950, 364260, 073230, 465380, 488040, 554610, 605670, 605680, 623070, 641630, 673680, 673700, 673710, 673730, 689790, 689800, 758490, 810930, 810940, 834770, 834780, 834790, 885300, 518350R, 697030R, 885210, 644470R, 865720, 865730, 865770, 885240, 885270, 885280, 834810, 865750, 885220, 885250, 885310, 865670, 865700, 865740, 910020, 910060, 924640, 946710, 973850, 518420, 002310, 002320, 002330, 002340, 034900, 946720, 946730, 946750, 946760, 910040. ***UDI Numbers*** (01)00880304521230(17)160628(10)996010, (01)00880304521230(17)170328(10)795510, (01)00880304521230(17)170628(10)603900, (01)00880304521230(17)170928(10)891790, (01)00880304521230(17)171128(10)437190, (01)00880304521230(17)171128(10)735730, (01)00880304521230(17)180128(10)403040, (01)00880304521230(17)180204(10)474110, (01)00880304521230(17)180307(10)766880, (01)00880304521230(17)180306(10)819080, (01)00880304521230(17)180401(10)949560, (01)00880304521230(17)180401(10)982930, (01)00880304521230(17)180410(10)063520, (01)00880304521230(17)180509(10)277390, (01)00880304521230(17)180510(10)348170, (01)00880304521230(17)180621(10)649140, (01)00880304521230(17)180628(10)649130, 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(01)00880304521230(17)240927(10)777240, (01)00880304521230(17)240926(10)788240, (01)00880304521230(17)240926(10)806930, (01)00880304521230(17)241004(10)838060, (01)00880304521230(17)241002(10)894140, (01)00880304521230(17)241009(10)028960, (01)00880304521230(17)241009(10)900530, (01)00880304521230(17)241022(10)330950, (01)00880304521230(17)241022(10)364260, (01)00880304521230(17)241010(10)073230, (01)00880304521230(17)241108(10)465380, (01)00880304521230(17)241110(10)488040, (01)00880304521230(17)241119(10)554610, (01)00880304521230(17)241119(10)605670, (01)00880304521230(17)241119(10)605680, (01)00880304521230(17)241119(10)623070, (01)00880304521230(17)241119(10)641630, (01)00880304521230(17)241205(10)673680, (01)00880304521230(17)241204(10)673700, (01)00880304521230(17)241204(10)673710, (01)00880304521230(17)241205(10)673730, (01)00880304521230(17)241205(10)689790, (01)00880304521230(17)241204(10)689800, (01)00880304521230(17)241204(10)758490, (01)00880304521230(17)241217(10)810930, 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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 8 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

Z-1645-2020
Recall number
Z-1645-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 838930, 799860, 764700, 371690, 371700, 574530, 062130, 939190, 258290, 874960, 717990, 135090, 341030, 262420, 789510, 843130, 843140, 020980, 063530, 258130, 306890, 554960, 916060, 143900, 369930, 713250, 068170, 135800, 387420, 266430, 817720, 424890, 271580, 467100, 158310, 158320, 158330, 063490, 188750, 188760, 388720, 847530, 061820, 354330, 354340, 816470, 816710, 374910, 374920, 374940, 670140, 655470, 792140, 655460, 722930, 792130, 092510, 205800, 364730, 655480, 759150, 771240, 799960, 770950, 770970, 064050, 981350, 691930, 683120, 683170, 683150, 803380, 691880, 912490, 912500, 624150, 624160, 444030, 564610, 563840, 996120, 777720, 777730, 866050, 866070, 444030R, 655460R, 205800R, 116150, 232830, 946080, 232790, 232820, 438450, 453800, 453820, 453840, 477550, 477580, 477590, 547510, 438360, 438420, 453810, 453850, 477570, 477600, 547520, 784740, 438280, 438320, 438380, 547470, 561190, 547490, 453750, 946070, 164130, 453780, 164140, 431330, 683120R, 034680, 950380, 988870, 618540, 875430, 988910, 275310, 303400, 736780, 143600, 438220, 438430, 934880, 935040, 042490, 453750R, 770970R, 518530, 478470, 478480, 478500, 518520, 518540, 261860, 518500, 639250, 639280, 639310, 639350, 639370, 639380, 639240, 639270, 639340, 662040, 662060, 518510, 778040, 518490, 662080, 261870, 403980, 662050, 717850, 742340, 777310, 777330, 777340, 777380, 778100, 812880, 812890, 813510, 813530, 845400, 845420, 845440, 845450, 845470, 845480, 877510, 877530, 518470, 063800, 092510R, 374910R, 063790, 063810, 210670, 210690, 639300, 777250, 788250, 788430, 807220, 788200, 788420, 806950, 806960, 807210, 894160, 028970, 029010, 029020, 807200, 894150, 331320, 330960, 438360R, 465390, 465400, 503380, 503450, 503850, 641640, 641670, 689810, 689820, 689830, 723480, 723490, 723500, 723530, 834840, 865820, 865840, 834830, 834850, 865810, 723540, 865800, 865830, 910070, 910080, 002410, 946770, 946780, 946790, 946800, 946820. ***UDI Numbers*** 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(01)00880304521247(17)240512(10)639250, (01)00880304521247(17)240513(10)639280, (01)00880304521247(17)240512(10)639310, (01)00880304521247(17)240513(10)639350, (01)00880304521247(17)240512(10)639370, (01)00880304521247(17)240512(10)639380, (01)00880304521247(17)240515(10)639240, (01)00880304521247(17)240515(10)639270, (01)00880304521247(17)240515(10)639340, (01)00880304521247(17)240516(10)662040, (01)00880304521247(17)240516(10)662060, (01)00880304521247(17)240525(10)518510, (01)00880304521247(17)240526(10)778040, (01)00880304521247(17)240607(10)518490, (01)00880304521247(17)240609(10)662080, (01)00880304521247(17)240515(10)261870, (01)00880304521247(17)240628(10)403980, (01)00880304521247(17)240601(10)662050, (01)00880304521247(17)240611(10)717850, (01)00880304521247(17)240802(10)742340, (01)00880304521247(17)240526(10)777310, (01)00880304521247(17)240528(10)777330, (01)00880304521247(17)240702(10)777340, (01)00880304521247(17)240622(10)777380, (01)00880304521247(17)240528(10)778100, (01)00880304521247(17)240612(10)812880, (01)00880304521247(17)240802(10)812890, (01)00880304521247(17)240615(10)813510, (01)00880304521247(17)240611(10)813530, (01)00880304521247(17)240622(10)845400, (01)00880304521247(17)240620(10)845420, (01)00880304521247(17)240620(10)845440, (01)00880304521247(17)240801(10)845450, (01)00880304521247(17)240622(10)845470, (01)00880304521247(17)240620(10)845480, (01)00880304521247(17)240617(10)877510, (01)00880304521247(17)240614(10)877530, (01)00880304521247(17)240805(10)518470, (01)00880304521247(17)240816(10)063800, (01)00880304521247(17)200917(10)092510R, (01)00880304521247(17)200707(10)374910R, (01)00880304521247(17)240828(10)063790, (01)00880304521247(17)240828(10)063810, (01)00880304521247(17)240828(10)210670, (01)00880304521247(17)240828(10)210690, (01)00880304521247(17)240927(10)639300, (01)00880304521247(17)240926(10)777250, (01)00880304521247(17)240926(10)788250, (01)00880304521247(17)240927(10)788430, (01)00880304521247(17)240927(10)807220, (01)00880304521247(17)241003(10)788200, (01)00880304521247(17)241003(10)788420, (01)00880304521247(17)241003(10)806950, (01)00880304521247(17)241003(10)806960, (01)00880304521247(17)241003(10)807210, (01)00880304521247(17)241003(10)894160, (01)00880304521247(17)241010(10)028970, (01)00880304521247(17)241010(10)029010, (01)00880304521247(17)241010(10)029020, (01)00880304521247(17)241009(10)807200, (01)00880304521247(17)241008(10)894150, (01)00880304521247(17)241022(10)331320, (01)00880304521247(17)241023(10)330960, (01)00880304521247(17)221109(10)438360R, (01)00880304521247(17)241110(10)465390, (01)00880304521247(17)241110(10)465400, (01)00880304521247(17)241110(10)503380, (01)00880304521247(17)241108(10)503450, (01)00880304521247(17)241107(10)503850, (01)00880304521247(17)241119(10)641640, (01)00880304521247(17)241119(10)641670, (01)00880304521247(17)241206(10)689810, (01)00880304521247(17)241206(10)689820, (01)00880304521247(17)241208(10)689830, (01)00880304521247(17)241208(10)723480, (01)00880304521247(17)241209(10)723490, (01)00880304521247(17)241208(10)723500, (01)00880304521247(17)241208(10)723530, (01)00880304521247(17)241217(10)834840, (01)00880304521247(17)241218(10)834860, (01)00880304521247(17)241217(10)865820, (01)00880304521247(17)241218(10)865840, (01)00880304521247(17)241218(10)834830, (01)00880304521247(17)241218(10)834850, (01)00880304521247(17)241218(10)865810, (01)00880304521247(17)250102(10)723540, (01)00880304521247(17)250102(10)865800, (01)00880304521247(17)241217(10)865830, (01)00880304521247(17)250111(10)910070, (01)00880304521247(17)250113(10)910080, (01)00880304521247(17)250122(10)002410, (01)00880304521247(17)250121(10)946770, (01)00880304521247(17)250121(10)946780, (01)00880304521247(17)250122(10)946790, (01)00880304521247(17)250122(10)946800 (01)00880304521247(17)250121(10)946820

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 9 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

Z-1646-2020
Recall number
Z-1646-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 087760, 558520, 558530, 654110, 469440, 926010, 718110, 083550, 341040, 474120, 662900, 306900, 914850, 265670, 551790, 941370, 941390, 817670, 158400, 141900, 188770, 061830, 463840, 364220, 816770, 816790, 374950, 655500, 792150, 092520, 655490, 770990, 683080, 683090, 981350, 997440, 997450, 912470, 912480, 624170, 624180, 665060, 552360, 265670R, 306900R, 232960, 233000, 233060, 547570, 547670, 552360R, 226520, 809460, 547650, 547680, 809270, 071410, 071430, 071450, 164150, 223370, 431360, 487280, 552580, 401640, 401650, 401670, 295510, 941390R, 226530, 143780, 303410, 737410, 988920, 223390, 295520, 920600, 683080R, 639430, 639490, 639540, 639550, 639510, 639530, 639560, 639590, 777450, 777570, 777600, 052660, 312640, 455040, 639440, 639480, 765330, 765340, 777390, 778120, 778130, 813840, 877540, 037550, 210740, 547570R, 709650, 777290, 777300, 788910, 807230, 807240, 856340, 029030, 029050, 807260, 330970, 813820, 465410, 488050, 554620, 554630, 554660, 605690, 657890, 758500, 807230R, 810950, 865860, 865890, 910090, 910120, 946910. ***UDI Numbers*** (01)00880304521179(17)160728(10)087760, (01)00880304521179(17)160828(10)558520, (01)00880304521179(17)160828(10)558530, (01)00880304521179(17)160928(10)654110, (01)00880304521179(17)161228(10)469440, (01)00880304521179(17)170928(10)926010, (01)00880304521179(17)171207(10)718110, (01)00880304521179(17)171228(10)083550, (01)00880304521179(17)180118(10)341040, (01)00880304521179(17)180130(10)474120, (01)00880304521179(17)180218(10)662900, (01)00880304521179(17)180503(10)306900, (01)00880304521179(17)180731(10)914850, (01)00880304521179(17)180827(10)265670, (01)00880304521179(17)180926(10)551790, (01)00880304521179(17)190218(10)941370, (01)00880304521179(17)190224(10)941390, (01)00880304521179(17)191016(10)817670, (01)00880304521179(17)190822(10)158400, (01)00880304521179(17)191103(10)141900, (01)00880304521179(17)191202(10)188770, (01)00880304521179(17)200218(10)061830, (01)00880304521179(17)200219(10)463840, (01)00880304521179(17)200324(10)364220, (01)00880304521179(17)200513(10)816770, (01)00880304521179(17)200514(10)816790, (01)00880304521179(17)200713(10)374950, (01)00880304521179(17)200805(10)655500, (01)00880304521179(17)200831(10)792150, (01)00880304521179(17)200917(10)092520, (01)00880304521179(17)200813(10)655490, (01)00880304521179(17)201120(10)770990, (01)00880304521179(17)210202(10)683080, (01)00880304521179(17)210203(10)683090, (01)00880304521179(17)210307(10)981350, (01)00880304521179(17)210308(10)997440, (01)00880304521179(17)210308(10)997450, (01)00880304521179(17)210601(10)912470, (01)00880304521179(17)210602(10)912480, (01)00880304521179(17)210721(10)624170, (01)00880304521179(17)210722(10)624180, (01)00880304521179(17)210728(10)665060, (01)00880304521179(17)211102(10)552360, (01)00880304521179(17)180827(10)265670R, (01)00880304521179(17)180503(10)306900R, (01)00880304521179(17)220725(10)232960, (01)00880304521179(17)220725(10)233000, (01)00880304521179(17)220725(10)233060, (01)00880304521179(17)220822(10)547570, (01)00880304521179(17)220822(10)547670, (01)00880304521179(17)211102(10)552360R, (01)00880304521179(17)220906(10)226520, (01)00880304521179(17)221130(10)809460, (01)00880304521179(17)221211(10)547650, (01)00880304521179(17)221207(10)547680, (01)00880304521179(17)221206(10)809270, (01)00880304521179(17)221229(10)071410, (01)00880304521179(17)230106(10)071430, (01)00880304521179(17)221227(10)071450, (01)00880304521179(17)230106(10)164150, (01)00880304521179(17)230122(10)223370, (01)00880304521179(17)230122(10)431360, (01)00880304521179(17)230122(10)487280, (01)00880304521179(17)230122(10)552580, (01)00880304521179(17)230125(10)401640, (01)00880304521179(17)230125(10)401650, (01)00880304521179(17)230125(10)401670, (01)00880304521179(17)230306(10)295510, (01)00880304521179(17)190224(10)941390R, (01)00880304521179(17)221019(10)226530, (01)00880304521179(17)230413(10)143780, (01)00880304521179(17)230414(10)303410, (01)00880304521179(17)230412(10)737410, (01)00880304521179(17)230412(10)988920, (01)00880304521179(17)221229(10)223390, (01)00880304521179(17)230125(10)295520, (01)00880304521179(17)230505(10)920600, (01)00880304521179(17)210202(10)683080R, (01)00880304521179(17)240514(10)639430, (01)00880304521179(17)240514(10)639490, (01)00880304521179(17)240514(10)639540, (01)00880304521179(17)240514(10)639550, (01)00880304521179(17)240514(10)639510, (01)00880304521179(17)240516(10)639530, (01)00880304521179(17)240514(10)639560, (01)00880304521179(17)240514(10)639590, (01)00880304521179(17)240525(10)777450, (01)00880304521179(17)240525(10)777570, (01)00880304521179(17)240607(10)777600, (01)00880304521179(17)240618(10)052660, (01)00880304521179(17)240613(10)312640, (01)00880304521179(17)240717(10)455040, (01)00880304521179(17)240729(10)639440, (01)00880304521179(17)240514(10)639480, (01)00880304521179(17)240607(10)765330, (01)00880304521179(17)240607(10)765340, (01)00880304521179(17)240618(10)777390, (01)00880304521179(17)240607(10)778120, (01)00880304521179(17)240623(10)778130, (01)00880304521179(17)240623(10)813840, (01)00880304521179(17)240618(10)877540, (01)00880304521179(17)240830(10)037550, (01)00880304521179(17)240830(10)210740, (01)00880304521179(17)220822(10)547570R, (01)00880304521179(17)240925(10)709650, (01)00880304521179(17)240924(10)777290, (01)00880304521179(17)241001(10)777300, (01)00880304521179(17)240926(10)788910, (01)00880304521179(17)241003(10)807230, (01)00880304521179(17)241003(10)807240, (01)00880304521179(17)241003(10)856340, (01)00880304521179(17)241012(10)029030, (01)00880304521179(17)241012(10)029050, (01)00880304521179(17)241011(10)807260, (01)00880304521179(17)241023(10)330970, (01)00880304521179(17)241023(10)813820, (01)00880304521179(17)241105(10)465410, (01)00880304521179(17)241105(10)488050, (01)00880304521179(17)241119(10)554620, (01)00880304521179(17)241118(10)554630, (01)00880304521179(17)241119(10)554660, (01)00880304521179(17)241119(10)605690, (01)00880304521179(17)241205(10)657890, (01)00880304521179(17)241205(10)758500, (01)00880304521179(17)241003(10)807230R, (01)00880304521179(17)241217(10)810950, (01)00880304521179(17)241217(10)865860, (01)00880304521179(17)241218(10)865890, (01)00880304521179(17)250111(10)910090, (01)00880304521179(17)250111(10)910120, (01)00880304521179(17)250111(10)946910

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 10 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.

Z-1647-2020
Recall number
Z-1647-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 978860, 087790, 087800, 157940, 558560, 564460, 052410, 052420, 052430, 052470, 052480, 230620, 230650, 575290, 767190, 766930, 789110, 031190, 031210, 031320, 265710, 349900, 654570, 927670, 767300, 817690, 188780, 188790, 932920, 205930, 429810, 655510, 092640, 757250, 771000, 683180, 803570, 217230, 197360, 291810, 799130, 552560, 974130, 249280, 249290, 233870, 188790R, 547700, 116180, 071090, 071100, 116160, 784730, 946240, 767190R, 487340, 552590, 655510R, 431450, 617650, 617770, 736810, 988930, 934780, 920630, 092640R, 552560R, 799130R, 920630R, 233870R, 291810R. ***UDI Numbers*** (01)00880304521155(17)160628(10)978860, (01)00880304521155(17)160728(10)087790, (01)00880304521155(17)160728(10)087800, (01)00880304521155(17)160728(10)157940, (01)00880304521155(17)160831(10)558560, (01)00880304521155(17)160928(10)564460, (01)00880304521155(17)170228(10)052410, (01)00880304521155(17)170228(10)052420, (01)00880304521155(17)170228(10)052430, (01)00880304521155(17)170228(10)052470, (01)00880304521155(17)170228(10)052480, (01)00880304521155(17)180108(10)230620, (01)00880304521155(17)180108(10)230650, (01)00880304521155(17)180215(10)575290, (01)00880304521155(17)180307(10)767190, (01)00880304521155(17)180330(10)766930, (01)00880304521155(17)180313(10)789110, (01)00880304521155(17)180430(10)031190, (01)00880304521155(17)180405(10)031210, (01)00880304521155(17)180405(10)031320, (01)00880304521155(17)181101(10)265710, (01)00880304521155(17)190101(10)349900, (01)00880304521155(17)190731(10)654570, (01)00880304521155(17)190807(10)927670, (01)00880304521155(17)190814(10)767300, (01)00880304521155(17)190813(10)817690, (01)00880304521155(17)191202(10)188780, (01)00880304521155(17)191204(10)188790, (01)00880304521155(17)200511(10)932920, (01)00880304521155(17)200609(10)205930, (01)00880304521155(17)200722(10)429810, (01)00880304521155(17)200805(10)655510, (01)00880304521155(17)201019(10)092640, (01)00880304521155(17)201109(10)757250, (01)00880304521155(17)201208(10)771000, (01)00880304521155(17)210215(10)683180, (01)00880304521155(17)210222(10)803570, (01)00880304521155(17)210321(10)217230, (01)00880304521155(17)210330(10)197360, (01)00880304521155(17)210616(10)291810, (01)00880304521155(17)210831(10)799130, (01)00880304521155(17)211105(10)552560, (01)00880304521155(17)220629(10)974130, (01)00880304521155(17)220518(10)249280, (01)00880304521155(17)220524(10)249290, (01)00880304521155(17)220726(10)233870, (01)00880304521155(17)191204(10)188790R, (01)00880304521155(17)221211(10)547700, (01)00880304521155(17)221219(10)116180, (01)00880304521155(17)221229(10)071090, (01)00880304521155(17)230109(10)071100, (01)00880304521155(17)221229(10)116160, (01)00880304521155(17)221227(10)784730, (01)00880304521155(17)230115(10)946240, (01)00880304521155(17)180307(10)767190R, (01)00880304521155(17)230320(10)487340, (01)00880304521155(17)230321(10)552590, (01)00880304521155(17)200805(10)655510R, (01)00880304521155(17)230321(10)431450, (01)00880304521155(17)230328(10)617650, (01)00880304521155(17)230416(10)617770, (01)00880304521155(17)230415(10)736810, (01)00880304521155(17)230412(10)988930, (01)00880304521155(17)230507(10)934780, (01)00880304521155(17)230511(10)920630, (01)00880304521155(17)201019(10)092640R, (01)00880304521155(17)211105(10)552560R, (01)00880304521155(17)210831(10)799130R, (01)00880304521155(17)230511(10)920630R, (01)00880304521155(17)220726(10)233870R, (01)00880304521155(17)210616(10)291810R

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 11 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

Z-1648-2020
Recall number
Z-1648-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 978870, 104900, 469480, 804270, 254080, 573990, 574110, 437220, 794520, 084260, 474130, 321640, 697120, 767230, 843180, 021340, 953860, 348180, 916270, 167360, 197180, 551810, 584740, 817740, 160680, 740340, 188800, 463930, 061840, 354870, 817100, 077680, 077700, 415570, 792220, 792200, 205880, 792210, 097970, 771010, 039320, 771170, 332950, 774510, 774430, 008820, 057700, 291820, 291930, 799140, 130820, 777420, 777450, 099660, 070950, 116190, 224060, 224170, 388090, 295570, 295590, 388150, 388180, 388250, 388280, 205880R, 099650, 736980, 737020, 712120, 736920, 988950, 548310, 034740, 275320, 303420, 359610, 946250, 988940, 740340R, 920850, 934760, 717470, 717510, 717530, 717540, 717550, 717560, 717570, 717590, 717440, 717480, 717490, 717520, 777640, 778140, 813850, 813870, 845500, 845510, 845520, 845530, 845540, 717460, 037570, 771010R, 084010, 037580, 152370, 717450, 326070, 717580, 580070, 772740, 788920, 788930, 777610, 789000, 807290, 807430, 807440, 807450, 029270, 055400, 580060, 807270, 807280, 807300, 807420, 883830, 807410, 792210R, 503860, 641730, 554670, 673760, 673770, 673780. ***UDI Numbers*** (01)00880304521124(17)160628(10)978870, (01)00880304521124(17)160728(10)104900, (01)00880304521124(17)161228(10)469480, (01)00880304521124(17)170228(10)804270, (01)00880304521124(17)170828(10)254080, (01)00880304521124(17)170828(10)573990, (01)00880304521124(17)170828(10)574110, (01)00880304521124(17)171028(10)437220, (01)00880304521124(17)171206(10)794520, (01)00880304521124(17)171221(10)084260, (01)00880304521124(17)180201(10)474130, (01)00880304521124(17)180211(10)321640, (01)00880304521124(17)180219(10)697120, (01)00880304521124(17)180306(10)767230, (01)00880304521124(17)180312(10)843180, (01)00880304521124(17)180329(10)021340, (01)00880304521124(17)180401(10)953860, (01)00880304521124(17)180510(10)348180, (01)00880304521124(17)180806(10)916270, (01)00880304521124(17)180831(10)167360, (01)00880304521124(17)180817(10)197180, (01)00880304521124(17)180925(10)551810, (01)00880304521124(17)190228(10)584740, (01)00880304521124(17)190513(10)817740, (01)00880304521124(17)190822(10)160680, (01)00880304521124(17)191024(10)740340, (01)00880304521124(17)191202(10)188800, (01)00880304521124(17)200112(10)463930, (01)00880304521124(17)200218(10)061840, (01)00880304521124(17)200410(10)354870, (01)00880304521124(17)200513(10)817100, (01)00880304521124(17)200609(10)077680, (01)00880304521124(17)200609(10)077700, (01)00880304521124(17)200710(10)415570, (01)00880304521124(17)200811(10)792220, (01)00880304521124(17)200901(10)792200, (01)00880304521124(17)200921(10)205880, (01)00880304521124(17)201001(10)792210, (01)00880304521124(17)201111(10)097970, (01)00880304521124(17)201112(10)771010, (01)00880304521124(17)201112(10)039320, (01)00880304521124(17)201112(10)771170, (01)00880304521124(17)210204(10)332950, (01)00880304521124(17)210215(10)774510, (01)00880304521124(17)210219(10)774430, (01)00880304521124(17)210318(10)008820, (01)00880304521124(17)210406(10)057700, (01)00880304521124(17)210615(10)291820, (01)00880304521124(17)210615(10)291930, (01)00880304521124(17)210830(10)799140, (01)00880304521124(17)210831(10)130820, (01)00880304521124(17)220329(10)777420, (01)00880304521124(17)220329(10)777450, (01)00880304521124(17)220725(10)099660, (01)00880304521124(17)221230(10)070950, (01)00880304521124(17)221207(10)116190, (01)00880304521124(17)221231(10)224060, (01)00880304521124(17)230123(10)224170, (01)00880304521124(17)230125(10)388090, (01)00880304521124(17)230125(10)295570, (01)00880304521124(17)230127(10)295590, (01)00880304521124(17)230125(10)388150, (01)00880304521124(17)230129(10)388180, (01)00880304521124(17)230131(10)388250, (01)00880304521124(17)230125(10)388280, (01)00880304521124(17)200921(10)205880R, (01)00880304521124(17)230223(10)099650, (01)00880304521124(17)230301(10)736980, (01)00880304521124(17)230306(10)737020, (01)00880304521124(17)230313(10)712120, (01)00880304521124(17)230307(10)736920, (01)00880304521124(17)230314(10)988950, (01)00880304521124(17)230321(10)548310, (01)00880304521124(17)230321(10)034740, (01)00880304521124(17)230412(10)275320, (01)00880304521124(17)230413(10)303420, (01)00880304521124(17)230412(10)359610, (01)00880304521124(17)221207(10)946250, (01)00880304521124(17)230417(10)988940, (01)00880304521124(17)191024(10)740340R, (01)00880304521124(17)230507(10)920850, (01)00880304521124(17)230510(10)934760, (01)00880304521124(17)240527(10)717470, (01)00880304521124(17)240527(10)717510, (01)00880304521124(17)240525(10)717530, (01)00880304521124(17)240524(10)717540, (01)00880304521124(17)240523(10)717550, (01)00880304521124(17)240525(10)717560, (01)00880304521124(17)240527(10)717570, (01)00880304521124(17)240524(10)717590, (01)00880304521124(17)240527(10)717440, (01)00880304521124(17)240618(10)717480, (01)00880304521124(17)240529(10)717490, (01)00880304521124(17)240528(10)717520, (01)00880304521124(17)240617(10)777640, (01)00880304521124(17)240612(10)778140, (01)00880304521124(17)240614(10)813850, (01)00880304521124(17)240612(10)813870, (01)00880304521124(17)240623(10)845500, (01)00880304521124(17)240616(10)845510, (01)00880304521124(17)240617(10)845520, (01)00880304521124(17)240617(10)845530, (01)00880304521124(17)240802(10)845540, (01)00880304521124(17)240810(10)717460, (01)00880304521124(17)240819(10)037570, (01)00880304521124(17)201112(10)771010R, (01)00880304521124(17)240819(10)084010, (01)00880304521124(17)240828(10)037580, (01)00880304521124(17)240830(10)152370, (01)00880304521124(17)240825(10)717450, (01)00880304521124(17)240912(10)326070, (01)00880304521124(17)240917(10)717580, (01)00880304521124(17)240927(10)580070, (01)00880304521124(17)240926(10)772740, (01)00880304521124(17)240926(10)788920, (01)00880304521124(17)240925(10)788930, (01)00880304521124(17)241004(10)777610, (01)00880304521124(17)241002(10)789000, (01)00880304521124(17)241009(10)807290, (01)00880304521124(17)241003(10)807430, (01)00880304521124(17)241003(10)807440, (01)00880304521124(17)241003(10)807450, (01)00880304521124(17)241011(10)029270, (01)00880304521124(17)241011(10)055400, (01)00880304521124(17)241011(10)580060, (01)00880304521124(17)241011(10)807270, (01)00880304521124(17)241011(10)807280, (01)00880304521124(17)241011(10)807300, (01)00880304521124(17)241011(10)807420, (01)00880304521124(17)241010(10)883830, (01)00880304521124(17)241105(10)807410, (01)00880304521124(17)201001(10)792210R, (01)00880304521124(17)241120(10)503860, (01)00880304521124(17)241119(10)641730, (01)00880304521124(17)241119(10)554670, (01)00880304521124(17)241211(10)673760, (01)00880304521124(17)241205(10)673770, (01)00880304521124(17)241205(10)673780

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 12 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

Z-1649-2020
Recall number
Z-1649-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 188860, 326860, 558630, 628180, 977670, 116350, 122520, 437230, 437290, 740330, 341070, 576690, 789080, 063540, 555070, 916280, 167510, 200790, 388910, 551820, 408270, 135820, 359260, 726800, 589000, 739960, 056940, 188810, 846790, 043650, 061850, 356930, 817130, 817180, 374980, 655520, 655530, 655540, 940150, 205910, 745770, 771020, 771030, 030880, 774440, 803790, 997470, 997500, 336220, 291950, 130830, 396920, 396930, 564620, 777740, 323510, 633930, 633940, 655650, 817180R, 548570, 946280, 116220, 438820, 453240, 224260, 438760, 453250, 916090, 916100, 946330, 295870, 431490, 070870, 070880, 438790, 388350, 548590, 737050, 275360, 359630, 712130, 034750, 275350, 737040, 950390, 974350, 989000, 042720, 144790, 179610, 478530, 478580, 478590, 639710, 639720, 639730, 639740, 639770, 639700, 262090, 262110, 404030, 404070, 717660, 717670, 717700, 717710, 717720, 717730, 717740, 717750, 777660, 845560, 877570, 037590, 063850, 210780, 789020, 717680, 789010, 029280, 073240, 807470, 807480, 807490, 807510, 807520, 894620, 330980, 465430, 548590R, 554680, 554690, 585440, 673800, 673820, 723570, 758520, 865920, 885460, 810970, 865910, 885430, 924720, 034970, 885440, 924690, 924700, 946970, 946980. ***UDI Numbers*** (01)00880304521117(17)160128(10)188860, (01)00880304521117(17)160728(10)326860, (01)00880304521117(17)160828(10)558630, (01)00880304521117(17)160928(10)628180, (01)00880304521117(17)161128(10)977670, (01)00880304521117(17)170728(10)116350, (01)00880304521117(17)170728(10)122520, (01)00880304521117(17)171028(10)437230, (01)00880304521117(17)171028(10)437290, (01)00880304521117(17)171128(10)740330, (01)00880304521117(17)180128(10)341070, (01)00880304521117(17)180219(10)576690, (01)00880304521117(17)180307(10)789080, (01)00880304521117(17)180410(10)063540, (01)00880304521117(17)180619(10)555070, (01)00880304521117(17)180831(10)916280, (01)00880304521117(17)180820(10)167510, (01)00880304521117(17)180903(10)200790, (01)00880304521117(17)180909(10)388910, (01)00880304521117(17)180925(10)551820, (01)00880304521117(17)180926(10)408270, (01)00880304521117(17)181205(10)135820, (01)00880304521117(17)190414(10)359260, (01)00880304521117(17)190801(10)726800, (01)00880304521117(17)190929(10)589000, (01)00880304521117(17)191010(10)739960, (01)00880304521117(17)191103(10)056940, (01)00880304521117(17)191202(10)188810, (01)00880304521117(17)200128(10)846790, (01)00880304521117(17)200203(10)043650, (01)00880304521117(17)200313(10)061850, (01)00880304521117(17)200408(10)356930, (01)00880304521117(17)200518(10)817130, (01)00880304521117(17)200518(10)817180, (01)00880304521117(17)200707(10)374980, (01)00880304521117(17)200811(10)655520, (01)00880304521117(17)200812(10)655530, (01)00880304521117(17)200901(10)655540, (01)00880304521117(17)200901(10)940150, (01)00880304521117(17)201023(10)205910, (01)00880304521117(17)201112(10)745770, (01)00880304521117(17)201124(10)771020, (01)00880304521117(17)201124(10)771030, (01)00880304521117(17)201210(10)030880, (01)00880304521117(17)210218(10)774440, (01)00880304521117(17)210219(10)803790, (01)00880304521117(17)210303(10)997470, (01)00880304521117(17)210303(10)997500, (01)00880304521117(17)210330(10)336220, (01)00880304521117(17)210714(10)291950, (01)00880304521117(17)210824(10)130830, (01)00880304521117(17)210916(10)396920, (01)00880304521117(17)210927(10)396930, (01)00880304521117(17)211104(10)564620, (01)00880304521117(17)220329(10)777740, (01)00880304521117(17)220605(10)323510, (01)00880304521117(17)220612(10)633930, (01)00880304521117(17)220612(10)633940, (01)00880304521117(17)220612(10)655650, (01)00880304521117(17)200518(10)817180R, (01)00880304521117(17)221211(10)548570, (01)00880304521117(17)221208(10)946280, (01)00880304521117(17)221218(10)116220, (01)00880304521117(17)221216(10)438820, (01)00880304521117(17)221121(10)453240, (01)00880304521117(17)221231(10)224260, (01)00880304521117(17)221231(10)438760, (01)00880304521117(17)221231(10)453250, (01)00880304521117(17)230106(10)916090, (01)00880304521117(17)230106(10)916100, (01)00880304521117(17)221229(10)946330, (01)00880304521117(17)230114(10)295870, (01)00880304521117(17)230116(10)431490, (01)00880304521117(17)230118(10)070870, (01)00880304521117(17)230118(10)070880, (01)00880304521117(17)230124(10)438790, (01)00880304521117(17)230128(10)388350, (01)00880304521117(17)230201(10)548590, (01)00880304521117(17)230306(10)737050, (01)00880304521117(17)230411(10)275360, (01)00880304521117(17)230411(10)359630, (01)00880304521117(17)230411(10)712130, (01)00880304521117(17)230416(10)034750, (01)00880304521117(17)230411(10)275350, (01)00880304521117(17)230417(10)737040, (01)00880304521117(17)230417(10)950390, (01)00880304521117(17)230417(10)974350, (01)00880304521117(17)230411(10)989000, (01)00880304521117(17)230508(10)042720, (01)00880304521117(17)230511(10)144790, (01)00880304521117(17)230513(10)179610, (01)00880304521117(17)240510(10)478530, (01)00880304521117(17)240510(10)478580, (01)00880304521117(17)240512(10)478590, (01)00880304521117(17)240511(10)639710, (01)00880304521117(17)240514(10)639720, (01)00880304521117(17)240512(10)639730, (01)00880304521117(17)240513(10)639740, (01)00880304521117(17)240514(10)639770, (01)00880304521117(17)240515(10)639700, (01)00880304521117(17)240607(10)262090, (01)00880304521117(17)240529(10)262110 (01)00880304521117(17)240716(10)404030, (01)00880304521117(17)240716(10)404070, (01)00880304521117(17)240608(10)717660, (01)00880304521117(17)240612(10)717670, (01)00880304521117(17)240613(10)717700, (01)00880304521117(17)240611(10)717710, (01)00880304521117(17)240612(10)717720, (01)00880304521117(17)240612(10)717730, (01)00880304521117(17)240611(10)717740, (01)00880304521117(17)240611(10)717750, (01)00880304521117(17)240611(10)777660, (01)00880304521117(17)240616(10)845560, (01)00880304521117(17)240617(10)877570, (01)00880304521117(17)240819(10)037590, (01)00880304521117(17)240831(10)063850, (01)00880304521117(17)240829(10)210780, (01)00880304521117(17)240926(10)789020, (01)00880304521117(17)241003(10)717680, (01)00880304521117(17)241009(10)789010, (01)00880304521117(17)241011(10)029280, (01)00880304521117(17)241010(10)073240, (01)00880304521117(17)241009(10)807470, (01)00880304521117(17)241009(10)807480, (01)00880304521117(17)241009(10)807490, (01)00880304521117(17)241009(10)807510, (01)00880304521117(17)241009(10)807520, (01)00880304521117(17)241009(10)894620, (01)00880304521117(17)241023(10)330980, (01)00880304521117(17)241105(10)465430, (01)00880304521117(17)230201(10)548590R, (01)00880304521117(17)241118(10)554680, (01)00880304521117(17)241118(10)554690, (01)00880304521117(17)241118(10)585440, (01)00880304521117(17)241204(10)673800, (01)00880304521117(17)241204(10)673820, (01)00880304521117(17)241205(10)723570, (01)00880304521117(17)241206(10)758520, (01)00880304521117(17)241218(10)865920, (01)00880304521117(17)241218(10)885460, (01)00880304521117(17)250103(10)810970, (01)00880304521117(17)250110(10)865910, (01)00880304521117(17)250110(10)885430, (01)00880304521117(17)250110(10)924720, (01)00880304521117(17)250124(10)034970, (01)00880304521117(17)250123(10)885440, (01)00880304521117(17)250128(10)924690, (01)00880304521117(17)250123(10)924700, (01)00880304521117(17)250123(10)946970, (01)00880304521117(17)250124(10)946980

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 13 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

Z-1650-2020
Recall number
Z-1650-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 331870, 050670, 628200, 977700, 487840, 680310, 062930, 437310, 736420, 129860, 084270, 262430, 474140, 176350, 520540, 957200, 265730, 713220, 584750, 817700, 021270, 301460, 063240, 188820, 188830, 061870, 061860, 932970, 374990, 375000, 602360, 680450, 792230, 655550, 092840, 205930, 771040, 774460, 774450, 016170, 997520, 188490, 400250, 147560, 291850, 548320, 396960, 396950, 632020, 234510, 809670, 809680, 164180, 070740, 916120, 070650, 070710, 070720, 164170, 224520, 224530, 295880, 295890, 295900, 388410, 388430, 388440, 401930, 552620, 552630, 552640, 552650, 617990, 070690, 224510, 315420, 401920, 431570, 618010, 070730, 388420, 388460, 548610, 034780, 275370, 737120, 808040, 875330, 144810, 042920, 070730R, 639790, 639860, 639880, 639930, 262130, 639850, 639920, 639940, 639950, 313660, 313670, 326880, 374130, 717760, 717770, 717780, 717790, 717800, 717810, 717820, 717830, 717840, 812850, 813890, 813910, 809680R, 037600, 063860, 063870, 210830, 388460R, 772750, 806560, 806640, 806790, 029310, 807400, 807540, 894170, 117910, 250580, 331000, 488060, 554700, 605700, 673830, 689840, 689850, 834890, 813910R, 834900, 834920, 834880, 834910, 865950, 865940, 946990,***UDI Numbers*** (01)00880304521148(17)160128(10)331870, (01)00880304521148(17)160628(10)050670, (01)00880304521148(17)160928(10)628200, (01)00880304521148(17)161128(10)977700, (01)00880304521148(17)170428(10)487840, (01)00880304521148(17)170528(10)680310, (01)00880304521148(17)170628(10)062930, (01)00880304521148(17)171128(10)437310, (01)00880304521148(17)171206(10)736420, (01)00880304521148(17)171228(10)129860, (01)00880304521148(17)171228(10)084270, (01)00880304521148(17)180116(10)262430, (01)00880304521148(17)180203(10)474140, (01)00880304521148(17)180416(10)176350, (01)00880304521148(17)180619(10)520540, (01)00880304521148(17)180730(10)957200, (01)00880304521148(17)180826(10)265730, (01)00880304521148(17)181009(10)713220, (01)00880304521148(17)190114(10)584750, (01)00880304521148(17)190514(10)817700, (01)00880304521148(17)190814(10)021270, (01)00880304521148(17)190905(10)301460, (01)00880304521148(17)191031(10)063240, (01)00880304521148(17)191202(10)188820, (01)00880304521148(17)191202(10)188830, (01)00880304521148(17)200314(10)061870, (01)00880304521148(17)200323(10)061860, (01)00880304521148(17)200513(10)932970, (01)00880304521148(17)200706(10)374990, (01)00880304521148(17)200707(10)375000, (01)00880304521148(17)200722(10)602360, (01)00880304521148(17)200728(10)680450, (01)00880304521148(17)200812(10)792230, (01)00880304521148(17)200831(10)655550, (01)00880304521148(17)200921(10)092840, (01)00880304521148(17)201007(10)205930, (01)00880304521148(17)201124(10)771040, (01)00880304521148(17)210219(10)774460, (01)00880304521148(17)210301(10)774450, (01)00880304521148(17)210303(10)016170, (01)00880304521148(17)210308(10)997520, (01)00880304521148(17)210318(10)188490, (01)00880304521148(17)210406(10)400250, (01)00880304521148(17)210512(10)147560, (01)00880304521148(17)210714(10)291850, (01)00880304521148(17)210714(10)548320, (01)00880304521148(17)210915(10)396960, (01)00880304521148(17)211119(10)396950, (01)00880304521148(17)220417(10)632020, (01)00880304521148(17)220725(10)234510, (01)00880304521148(17)221218(10)809670, (01)00880304521148(17)221218(10)809680, (01)00880304521148(17)221228(10)164180, (01)00880304521148(17)230115(10)070740, (01)00880304521148(17)230115(10)916120, (01)00880304521148(17)230118(10)070650, (01)00880304521148(17)230124(10)070710, (01)00880304521148(17)230118(10)070720, (01)00880304521148(17)230125(10)164170, (01)00880304521148(17)230124(10)224520, (01)00880304521148(17)230124(10)224530, (01)00880304521148(17)230118(10)295880, (01)00880304521148(17)230119(10)295890, (01)00880304521148(17)230119(10)295900, (01)00880304521148(17)230124(10)388410, (01)00880304521148(17)230125(10)388430, (01)00880304521148(17)230124(10)388440, (01)00880304521148(17)230124(10)401930, (01)00880304521148(17)230118(10)552620, (01)00880304521148(17)230124(10)552630, (01)00880304521148(17)230124(10)552640, (01)00880304521148(17)230119(10)552650, (01)00880304521148(17)230123(10)617990, (01)00880304521148(17)230125(10)070690, (01)00880304521148(17)230124(10)224510, (01)00880304521148(17)230125(10)315420, (01)00880304521148(17)230128(10)401920, (01)00880304521148(17)230125(10)431570, (01)00880304521148(17)230125(10)618010, (01)00880304521148(17)230205(10)070730, (01)00880304521148(17)230312(10)388420, (01)00880304521148(17)230309(10)388460, (01)00880304521148(17)230408(10)548610, (01)00880304521148(17)230412(10)034780, (01)00880304521148(17)230416(10)275370, (01)00880304521148(17)230417(10)737120, (01)00880304521148(17)230412(10)808040, (01)00880304521148(17)230416(10)875330, (01)00880304521148(17)230420(10)144810, (01)00880304521148(17)230510(10)042920, (01)00880304521148(17)230205(10)070730R, (01)00880304521148(17)240513(10)639790, (01)00880304521148(17)240521(10)639860, (01)00880304521148(17)240520(10)639880, (01)00880304521148(17)240520(10)639930, (01)00880304521148(17)240525(10)262130, (01)00880304521148(17)240527(10)639850, (01)00880304521148(17)240521(10)639920, (01)00880304521148(17)240527(10)639940, (01)00880304521148(17)240527(10)639950, (01)00880304521148(17)240529(10)313660, (01)00880304521148(17)240529(10)313670, (01)00880304521148(17)240612(10)326880, (01)00880304521148(17)240716(10)374130, (01)00880304521148(17)240612(10)717760, (01)00880304521148(17)240613(10)717770, (01)00880304521148(17)240614(10)717780, (01)00880304521148(17)240611(10)717790, (01)00880304521148(17)240612(10)717800, (01)00880304521148(17)240616(10)717810, (01)00880304521148(17)240613(10)717820, (01)00880304521148(17)240613(10)717830, (01)00880304521148(17)240613(10)717840, (01)00880304521148(17)240612(10)812850, (01)00880304521148(17)240613(10)813890, (01)00880304521148(17)240613(10)813910, (01)00880304521148(17)221218(10)809680R, (01)00880304521148(17)240828(10)037600, (01)00880304521148(17)240830(10)063860, (01)00880304521148(17)240830(10)063870, (01)00880304521148(17)240830(10)210830, (01)00880304521148(17)230309(10)388460R, (01)00880304521148(17)241009(10)772750, (01)00880304521148(17)241009(10)806560, (01)00880304521148(17)241002(10)806640, (01)00880304521148(17)241002(10)806790, (01)00880304521148(17)241011(10)029310, (01)00880304521148(17)241011(10)807400, (01)00880304521148(17)241009(10)807540, (01)00880304521148(17)241009(10)894170, (01)00880304521148(17)241024(10)117910, (01)00880304521148(17)241024(10)250580, (01)00880304521148(17)241024(10)331000, (01)00880304521148(17)241106(10)488060, (01)00880304521148(17)241119(10)554700, (01)00880304521148(17)241119(10)605700, (01)00880304521148(17)241209(10)673830, (01)00880304521148(17)241204(10)689840, (01)00880304521148(17)241204(10)689850, (01)00880304521148(17)241218(10)834890, (01)00880304521148(17)240613(10)813910R, (01)00880304521148(17)241218(10)834900, (01)00880304521148(17)241219(10)834920, (01)00880304521148(17)250104(10)834880, (01)00880304521148(17)250104(10)834910, (01)00880304521148(17)250102(10)865950, (01)00880304521148(17)250110(10)865940, (01)00880304521148(17)250123(10)946990, (01)00880304521148(17)250123(10)973880 973880.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 14 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

Z-1651-2020
Recall number
Z-1651-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 104910, 157950, 326900, 326920, 652840, 684040, 471600, 593520, 940120, 437300, 091520, 474150, 576700, 110750, 672080, 143910, 713260, 359270, 529160, 160630, 301450, 188850, 188840, 886920, 066020, 364260, 077620, 077630, 429820, 492480, 661200, 092850, 771050, 997420, 997410, 291970, 291870, 799190, 397000, 564140, 564130, 997410R, 809850, 809870, 809910, 224890, 548620, 809890, 916180, 070370, 224900, 224940, 224950, 164220, 164270, 164320, 224930, 295910, 388560, 388610, 388630, 552720, 552740, 388620, 552730, 737160, 875440, 989030, 291870R, 359270R, 799190R, 275380, 035010, 950420, 042970, 179530, 388620R, 717600, 717630, 777730, 356080, 717610, 717640, 777680, 777720, 864800, 864810, 864820, 864830, 879760, 063880, 164320R, 809910R, 224930R, 777710, 580090, 789080, 807580, 029320, 807550, 807560, 807590, 717620, 073260, 073270, 364280, 364300, 488070, 525680, 554710, 641750, 641840, 673840, 770190, 835130, 885470, 947000. ***UDI Numbers*** (01)00880304521131(17)160728(10)104910, (01)00880304521131(17)160728(10)157950, (01)00880304521131(17)160828(10)326900, (01)00880304521131(17)160728(10)326920, (01)00880304521131(17)160928(10)652840, (01)00880304521131(17)160930(10)684040, (01)00880304521131(17)170428(10)471600, (01)00880304521131(17)170528(10)593520, (01)00880304521131(17)170928(10)940120, (01)00880304521131(17)171128(10)437300, (01)00880304521131(17)171201(10)091520, (01)00880304521131(17)180204(10)474150, (01)00880304521131(17)180212(10)576700, (01)00880304521131(17)180412(10)110750, (01)00880304521131(17)180702(10)672080, (01)00880304521131(17)180820(10)143910, (01)00880304521131(17)181031(10)713260, (01)00880304521131(17)190707(10)359270, (01)00880304521131(17)190708(10)529160, (01)00880304521131(17)190822(10)160630, (01)00880304521131(17)190906(10)301450, (01)00880304521131(17)191202(10)188850, (01)00880304521131(17)191230(10)188840, (01)00880304521131(17)200204(10)886920, (01)00880304521131(17)200506(10)066020, (01)00880304521131(17)200505(10)364260, (01)00880304521131(17)200608(10)077620, (01)00880304521131(17)200609(10)077630, (01)00880304521131(17)200710(10)429820, (01)00880304521131(17)200727(10)492480, (01)00880304521131(17)200728(10)661200, (01)00880304521131(17)201001(10)092850, (01)00880304521131(17)201117(10)771050, (01)00880304521131(17)210228(10)997420, (01)00880304521131(17)210303(10)997410, (01)00880304521131(17)210706(10)291970, (01)00880304521131(17)210713(10)291870, (01)00880304521131(17)210830(10)799190, (01)00880304521131(17)210912(10)397000, (01)00880304521131(17)211102(10)564140, (01)00880304521131(17)220420(10)564130, (01)00880304521131(17)210303(10)997410R, (01)00880304521131(17)221203(10)809850, (01)00880304521131(17)221214(10)809870, (01)00880304521131(17)221218(10)809910, (01)00880304521131(17)230109(10)224890, (01)00880304521131(17)221231(10)548620, (01)00880304521131(17)221228(10)809890, (01)00880304521131(17)221231(10)916180, (01)00880304521131(17)230115(10)070370, (01)00880304521131(17)230115(10)224900, (01)00880304521131(17)230115(10)224940, (01)00880304521131(17)230115(10)224950, (01)00880304521131(17)230118(10)164220, (01)00880304521131(17)230124(10)164270, (01)00880304521131(17)230115(10)164320, (01)00880304521131(17)230118(10)224930, (01)00880304521131(17)230124(10)295910, (01)00880304521131(17)230119(10)388560, (01)00880304521131(17)230119(10)388610, (01)00880304521131(17)230124(10)388630, (01)00880304521131(17)230119(10)552720, (01)00880304521131(17)230124(10)552740, (01)00880304521131(17)230128(10)388620, (01)00880304521131(17)230124(10)552730, (01)00880304521131(17)230220(10)737160, (01)00880304521131(17)230227(10)875440, (01)00880304521131(17)230228(10)989030, (01)00880304521131(17)210713(10)291870R, (01)00880304521131(17)190707(10)359270R, (01)00880304521131(17)210830(10)799190R, (01)00880304521131(17)230423(10)275380, (01)00880304521131(17)230430(10)035010, (01)00880304521131(17)230501(10)950420, (01)00880304521131(17)230507(10)042970, (01)00880304521131(17)230510(10)179530, (01)00880304521131(17)230128(10)388620R, (01)00880304521131(17)240527(10)717600, (01)00880304521131(17)240527(10)717630, (01)00880304521131(17)240527(10)777730, (01)00880304521131(17)240608(10)356080, (01)00880304521131(17)240528(10)717610, (01)00880304521131(17)240611(10)717640, (01)00880304521131(17)240805(10)777680, (01)00880304521131(17)240619(10)777720, (01)00880304521131(17)240615(10)864800, (01)00880304521131(17)240617(10)864810, (01)00880304521131(17)240626(10)864820, (01)00880304521131(17)240615(10)864830, (01)00880304521131(17)240813(10)879760, (01)00880304521131(17)240828(10)063880, (01)00880304521131(17)230115(10)164320R, (01)00880304521131(17)221218(10)809910R, (01)00880304521131(17)230118(10)224930R, (01)00880304521131(17)240912(10)777710, (01)00880304521131(17)240926(10)580090, (01)00880304521131(17)240926(10)789080, (01)00880304521131(17)241008(10)807580, (01)00880304521131(17)241011(10)029320, (01)00880304521131(17)241009(10)807550, (01)00880304521131(17)241010(10)807560, (01)00880304521131(17)241009(10)807590, (01)00880304521131(17)241018(10)717620, (01)00880304521131(17)241023(10)073260, (01)00880304521131(17)241023(10)073270, (01)00880304521131(17)241023(10)364280, (01)00880304521131(17)241023(10)364300, (01)00880304521131(17)241106(10)488070, (01)00880304521131(17)241106(10)525680, (01)00880304521131(17)241119(10)554710, (01)00880304521131(17)241119(10)641750, (01)00880304521131(17)241119(10)641840, (01)00880304521131(17)241205(10)673840, (01)00880304521131(17)250102(10)770190, (01)00880304521131(17)250105(10)835130, (01)00880304521131(17)250102(10)885470, (01)00880304521131(17)250128(10)947000

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 15 of 33

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.

Z-1652-2020
Recall number
Z-1652-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 288190, 288210, 580430, 612120, 574610, 521820, 736490, 406850, 767250, 348190, 265750, 851110, 549350, 266450, 301440, 188860, 464070, 994620, 701410, 939800, 112710, 119970, 375010, 661210, 661220, 205950, 596580, 774500, 997550, 145740, 291880, 799200, 397020, 552570, 799200R, 552570R, 070340, 708360, 708380, 708350, 810080, 225020, 618510, 737390, 618520, 388640, 487350, 737370, 737400, 275390, 950440, 548650, 708400, 848360, 596580R, 487350R,***UDI Numbers*** (01)00880304521162(17)160828(10)288190, (01)00880304521162(17)160828(10)288210, (01)00880304521162(17)170128(10)580430, (01)00880304521162(17)170528(10)612120, (01)00880304521162(17)170828(10)574610, (01)00880304521162(17)171101(10)521820, (01)00880304521162(17)180115(10)736490, (01)00880304521162(17)180121(10)406850, (01)00880304521162(17)180301(10)767250, (01)00880304521162(17)180522(10)348190, (01)00880304521162(17)181101(10)265750, (01)00880304521162(17)181130(10)851110, (01)00880304521162(17)190626(10)549350, (01)00880304521162(17)190731(10)266450, (01)00880304521162(17)190828(10)301440, (01)00880304521162(17)191125(10)188860, (01)00880304521162(17)200128(10)464070, (01)00880304521162(17)200206(10)994620, (01)00880304521162(17)200506(10)701410, (01)00880304521162(17)200506(10)939800, (01)00880304521162(17)200608(10)112710, (01)00880304521162(17)200609(10)119970, (01)00880304521162(17)200710(10)375010, (01)00880304521162(17)200729(10)661210, (01)00880304521162(17)200811(10)661220, (01)00880304521162(17)200930(10)205950, (01)00880304521162(17)210119(10)596580, (01)00880304521162(17)210218(10)774500, (01)00880304521162(17)210310(10)997550, (01)00880304521162(17)210502(10)145740, (01)00880304521162(17)210721(10)291880, (01)00880304521162(17)210824(10)799200, (01)00880304521162(17)210923(10)397020, (01)00880304521162(17)211112(10)552570, (01)00880304521162(17)210824(10)799200R, (01)00880304521162(17)211112(10)552570R, (01)00880304521162(17)230115(10)070340, (01)00880304521162(17)230202(10)708360, (01)00880304521162(17)230202(10)708380, (01)00880304521162(17)230202(10)708350, (01)00880304521162(17)230205(10)810080, (01)00880304521162(17)230224(10)225020, (01)00880304521162(17)230228(10)618510, (01)00880304521162(17)230223(10)737390, (01)00880304521162(17)230407(10)618520, (01)00880304521162(17)230415(10)388640, (01)00880304521162(17)230411(10)487350, (01)00880304521162(17)230416(10)737370, (01)00880304521162(17)230416(10)737400, (01)00880304521162(17)230422(10)275390, (01)00880304521162(17)230430(10)950440, (01)00880304521162(17)230514(10)548650, (01)00880304521162(17)230510(10)708400, (01)00880304521162(17)230625(10)848360, (01)00880304521162(17)210119(10)596580R, (01)00880304521162(17)230411(10)487350R, (01)00880304521162(17)210721(10)291880R 291880R.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 16 of 33

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

Z-1653-2020
Recall number
Z-1653-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 964120, 668270, 595770, 400860, 854840, 867720, 867770, 386480, 539790, 700450, 930290, 215340, 457040, 615020, 588170, 588180, 963900, 963890, 737920, 805810, 036350, 527200, 527910, 976890, 977050, 977060, 239180, 239350, 680230, 914070, 436930, 586660, 718000, 996950, 152820, 447320, 583910, 489590, 688970, 983790, 237740, 600740, 804850, 281760, 610610, 251390, 640340, 858260, 328590, 712140, 712150, 238320, 430100, 753810, 953120, 816080, 816070, 227680, 647310, 057570, 057580, 759520, 759530, 656320, 787060, 107920, 107930, 737780, 115700, 737760, 737770, 754930, 754940, 754960, 754970, 754980, 202410, 202420, 520120, 520130, 520140, 520150, 754960R, 705550, 964100R, 680230R, 807460, 825790R, 027710R, 766730, 520990, 520980, 521010, 234640, 234680, 208540R, 867750R, 347510, 347520, 348000, 347990, 318490, 318510, 318530, 318540, 337310, 337330, 350230, 337340, 350220, 350240, 383530, 449960, 449970, 350210, 449950, 457040R,***UDI Numbers*** (01)00880304447165(17)190428(10)964120, (01)00880304447165(17)190528(10)668270, (01)00880304447165(17)191028(10)595770, (01)00880304447165(17)200228(10)400860, (01)00880304447165(17)200428(10)854840, (01)00880304447165(17)200728(10)867720, (01)00880304447165(17)200728(10)867770, (01)00880304447165(17)200928(10)386480, (01)00880304447165(17)201028(10)539790, (01)00880304447165(17)201028(10)700450, (01)00880304447165(17)201128(10)930290, (01)00880304447165(17)201228(10)215340, (01)00880304447165(17)210128(10)457040, (01)00880304447165(17)210228(10)615020, (01)00880304447165(17)210928(10)588170, (01)00880304447165(17)210901(10)588180, (01)00880304447165(17)211028(10)963900, (01)00880304447165(17)211028(10)963890, (01)00880304447165(17)220728(10)737920, (01)00880304447165(17)221128(10)805810, (01)00880304447165(17)221206(10)036350, (01)00880304447165(17)230122(10)527200, (01)00880304447165(17)230122(10)527910, (01)00880304447165(17)230313(10)976890, (01)00880304447165(17)230312(10)977050, (01)00880304447165(17)230314(10)977060, (01)00880304447165(17)230428(10)239180, (01)00880304447165(17)230424(10)239350, (01)00880304447165(17)230612(10)680230, (01)00880304447165(17)230630(10)914070, (01)00880304447165(17)230827(10)436930, (01)00880304447165(17)230918(10)586660, (01)00880304447165(17)230927(10)718000, (01)00880304447165(17)231031(10)996950, (01)00880304447165(17)231107(10)152820, (01)00880304447165(17)231130(10)447320, (01)00880304447165(17)240103(10)583910, (01)00880304447165(17)240317(10)489590, (01)00880304447165(17)240402(10)688970, (01)00880304447165(17)240428(10)983790, (01)00880304447165(17)240518(10)237740, (01)00880304447165(17)240615(10)600740, (01)00880304447165(17)240709(10)804850, (01)00880304447165(17)240817(10)281760, (01)00880304447165(17)240915(10)610610, (01)00880304447165(17)241111(10)251390, (01)00880304447165(17)241209(10)640340, (01)00880304447165(17)250119(10)858260, (01)00880304447165(17)250225(10)328590, (01)00880304447165(17)250402(10)712140, (01)00880304447165(17)250410(10)712150, (01)00880304447165(17)250528(10)238320, (01)00880304447165(17)250611(10)430100, (01)00880304447165(17)250714(10)753810, (01)00880304447165(17)250804(10)953120, (01)00880304447165(17)251027(10)816080, (01)00880304447165(17)251029(10)816070, (01)00880304447165(17)251208(10)227680, (01)00880304447165(17)260107(10)647310, (01)00880304447165(17)260211(10)057570, (01)00880304447165(17)260212(10)057580, (01)00880304447165(17)260411(10)759520, (01)00880304447165(17)260408(10)759530, (01)00880304447165(17)260628(10)656320, (01)00880304447165(17)260715(10)787060, (01)00880304447165(17)260729(10)107920, (01)00880304447165(17)260729(10)107930, (01)00880304447165(17)270619(10)737780, (01)00880304447165(17)270626(10)115700, (01)00880304447165(17)270622(10)737760, (01)00880304447165(17)270622(10)737770, (01)00880304447165(17)270622(10)754930, (01)00880304447165(17)270625(10)754940, (01)00880304447165(17)270625(10)754960, (01)00880304447165(17)270625(10)754970, (01)00880304447165(17)270625(10)754980, (01)00880304447165(17)270630(10)202410, (01)00880304447165(17)270629(10)202420, (01)00880304447165(17)270726(10)520120, (01)00880304447165(17)270727(10)520130, (01)00880304447165(17)270726(10)520140, (01)00880304447165(17)270729(10)520150, (01)00880304447165(17)270625(10)754960R, (01)00880304447165(17)270927(10)705550, (01)00880304447165(17)190401(10)964100R, (01)00880304447165(17)230612(10)680230R, (01)00880304447165(17)270825(10)807460, (01)00880304447165(17)180801(10)825790R, (01)00880304447165(17)190401(10)027710R, (01)00880304447165(17)280322(10)766730, (01)00880304447165(17)280330(10)520990, (01)00880304447165(17)280405(10)520980, (01)00880304447165(17)280409(10)521010, (01)00880304447165(17)280430(10)234640, (01)00880304447165(17)280430(10)234680, (01)00880304447165(17)220601(10)208540R, (01)00880304447165(17)200701(10)867750R, (01)00880304447165(17)290211(10)347510, (01)00880304447165(17)290211(10)347520, (01)00880304447165(17)290222(10)348000, (01)00880304447165(17)290313(10)347990, (01)00880304447165(17)290402(10)318490, (01)00880304447165(17)290402(10)318510, (01)00880304447165(17)290403(10)318530, (01)00880304447165(17)290402(10)318540, (01)00880304447165(17)290402(10)337310, (01)00880304447165(17)290404(10)337330, (01)00880304447165(17)290408(10)350230, (01)00880304447165(17)290409(10)337340, (01)00880304447165(17)290410(10)350220, (01)00880304447165(17)290412(10)350240, (01)00880304447165(17)290422(10)383530, (01)00880304447165(17)290501(10)337350, (01)00880304447165(17)290501(10)449960, (01)00880304447165(17)290501(10)449970, (01)00880304447165(17)290502(10)350210, (01)00880304447165(17)290502(10)449950, (01)00880304447165(17)210101(10)457040R, (01)00880304447165(17)280405(10)520980R 520980R.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 17 of 33

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

Z-1654-2020
Recall number
Z-1654-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 411170, 928060, 453050, 008400, 008780, 162230, 160450, 160460, 160470, 078140, 212600, 473150, 147200, 668750, 668810, 235310, 235260, 565730, 565740, 565780, 565800, 565750, 230020, 096010, 096030, 095830, 688290, 688390, 688400, 976900, 977070, 977080, 239190, 239390, 310050, 310180, 310200, 757930, 978060, 107630, 219920, 260550, 436940, 572340, 572350, 718010, 910910, 996970, 139640, 215600, 447340, 518820, 712320, 270170, 411560, 525340, 619980, 789360, 983800, 207230, 356350, 600710, 658360, 804860, 115880, 274120, 411240, 512260, 610620, 719040, 039580, 735560, 735570, 160950, 628310, 627970, 628320, 628330, 711810, 711820, 765470, 284700, 284710, 488480, 488490, 488500, 051450, 051460, 051470, 051480, 051490, 051500, 162780, 607690, 607700, 722770, 723210, 038660, 038670, 428720, 647320, 647330, 774580, 428700, 994880, 229280, 229290, 740300, 740310, 935460, 935480, 241700, 241820, 409670, 409680, 521740, 521750, 417820, 417840, 417830, 513610, 235260R, 737800, 737810, 755040, 756770, 754990, 755010, 755030, 755060, 755100, 755110, 756790, 756810, 756820, 756830, 756840, 756870, 202430, 202450, 737790, 756850, 520170, 520180, 520190, 310180R, 705570, 705580, 732030, 668750R, 118140, 658600R, 378140, 378130, 378150, 378160, 378170, 520940, 765900, 765920, 765960, 766390, 766420, 766740, 766750, 765890, 766760, 520920, 765880, 765930, 765970, 043400, 043410, 043430, 043450, 043470, 765950, 310200R, 147210R, 409680R, 348050, 347610, 348010, 348020, 348030, 348040, 347660, 318550, 318600, 318640, 318760, 318770, 318820, 318840, 318560, 318580, 318590, 318610, 318810, 337410, 350260, 337370, 337430, 350300, 350310, 337390, 350330, 383540, 383560, 383580, 383590, 318620, 337450, 350290, 350320, 383570, 337380, 337420, 350270, 383550, 449980, 449990, 337400, 450030, 737800R, 754990R, 756820R, 756840R, 378130R, 241820R,***UDI Numbers*** (01)00880304447141(17)191028(10)411170, (01)00880304447141(17)191228(10)928060, (01)00880304447141(17)200228(10)453050, (01)00880304447141(17)200801(10)008400, (01)00880304447141(17)200828(10)008780, (01)00880304447141(17)200928(10)162230, (01)00880304447141(17)201128(10)160450, (01)00880304447141(17)201128(10)160460, (01)00880304447141(17)201128(10)160470, (01)00880304447141(17)210301(10)078140, (01)00880304447141(17)210328(10)212600, (01)00880304447141(17)210428(10)473150, (01)00880304447141(17)210728(10)147200, (01)00880304447141(17)210928(10)668750, (01)00880304447141(17)210928(10)668810, (01)00880304447141(17)211128(10)235310, (01)00880304447141(17)211128(10)235260, (01)00880304447141(17)220128(10)565730, (01)00880304447141(17)220128(10)565740, (01)00880304447141(17)220128(10)565780, (01)00880304447141(17)220128(10)565800, (01)00880304447141(17)220128(10)565750, (01)00880304447141(17)220928(10)230020, (01)00880304447141(17)221206(10)096010, (01)00880304447141(17)221206(10)096030, (01)00880304447141(17)221210(10)095830, (01)00880304447141(17)230213(10)688290, (01)00880304447141(17)230213(10)688390, (01)00880304447141(17)230215(10)688400, (01)00880304447141(17)230314(10)976900, (01)00880304447141(17)230312(10)977070, (01)00880304447141(17)230312(10)977080, (01)00880304447141(17)230424(10)239190, (01)00880304447141(17)230423(10)239390, (01)00880304447141(17)230423(10)310050, (01)00880304447141(17)230422(10)310180, (01)00880304447141(17)230422(10)310200, (01)00880304447141(17)230614(10)757930, (01)00880304447141(17)230715(10)978060, (01)00880304447141(17)230730(10)107630, (01)00880304447141(17)230808(10)219920, (01)00880304447141(17)230814(10)260550, (01)00880304447141(17)230826(10)436940, (01)00880304447141(17)230917(10)572340, (01)00880304447141(17)230916(10)572350, (01)00880304447141(17)230927(10)718010, (01)00880304447141(17)231016(10)910910, (01)00880304447141(17)231025(10)996970, (01)00880304447141(17)231107(10)139640, (01)00880304447141(17)231108(10)215600, (01)00880304447141(17)231202(10)447340, (01)00880304447141(17)231210(10)518820, (01)00880304447141(17)240108(10)712320, (01)00880304447141(17)240226(10)270170, (01)00880304447141(17)240304(10)411560, (01)00880304447141(17)240317(10)525340, (01)00880304447141(17)240328(10)619980, (01)00880304447141(17)240408(10)789360, (01)00880304447141(17)240428(10)983800, (01)00880304447141(17)240518(10)207230, (01)00880304447141(17)240602(10)356350, (01)00880304447141(17)240615(10)600710, (01)00880304447141(17)240622(10)658360, (01)00880304447141(17)240709(10)804860, (01)00880304447141(17)240730(10)115880, (01)00880304447141(17)240813(10)274120, (01)00880304447141(17)240825(10)411240, (01)00880304447141(17)240904(10)512260, (01)00880304447141(17)240911(10)610620, (01)00880304447141(17)240919(10)719040, (01)00880304447141(17)241016(10)039580, (01)00880304447141(17)241216(10)735560, (01)00880304447141(17)241222(10)735570, (01)00880304447141(17)250203(10)160950, (01)00880304447141(17)250324(10)628310, (01)00880304447141(17)250325(10)627970, (01)00880304447141(17)250327(10)628320, 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(01)00880304447141(17)270624(10)754990R, (01)00880304447141(17)270627(10)756820R, (01)00880304447141(17)270626(10)756840R, (01)00880304447141(17)280301(10)378130R, (01)00880304447141(17)260517(10)241820R (01)00880304447141(17)230814(10)260550R 260550R.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 18 of 33

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.

Z-1655-2020
Recall number
Z-1655-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 027900, 670510, 371230, 836660, 602430, 008340, 008360, 008380, 162240, 162250, 700500, 186490, 377390, 658100, 658110, 658120, 658130, 473170, 912530, 086110, 571910, 230030, 230050, 658620, 658640, 170090, 170070, 527210, 527930, 600440, 600500, 239200, 239400, 680240, 729290, 844520, 978070, 260560, 413060, 747280, 845740, 996980, 215490, 381730, 447360, 627970, 868840, 070900, 339490, 600720, 771050, 182020, 325410, 610630, 745470, 251400, 557660, 847720, 858270, 157440, 328640, 628360, 628430, 790270, 238740, 514580, 679770, 953140, 197720, 336630, 152540, 527470, 647360, 945690, 057590, 229330, 759540, 949860, 258720, 332610, 787070, 595080, 595090, 737830, 737840, 737850, 755150, 755160, 755170, 737860, 755120, 755130, 755140, 757300, 202130, 202460, 733920R, 733910R, 732040, 118130, 416640R, 141060, 141040, 378370, 378390, 765990, 766020, 766030, 766050, 766060, 043910, 921310, 766080, 234700, 234710, 473170R, 350740, 350940, 658620R, 347850, 347840, 347980, 347830, 157440R, 318670, 337700, 318660, 318680, 318690, 318860, 337580, 337650, 337660, 350360, 350370, 350390, 350540, 350560, 318850, 337460, 337500, 350380, 350550, 383600, 383610, 383630, 337470, 070900R,***UDI Numbers*** (01)00880304447172(17)190128(10)027900, (01)00880304447172(17)190628(10)670510, (01)00880304447172(17)200128(10)371230, (01)00880304447172(17)200428(10)836660, (01)00880304447172(17)200628(10)602430, (01)00880304447172(17)200828(10)008340, (01)00880304447172(17)200801(10)008360, (01)00880304447172(17)200828(10)008380, (01)00880304447172(17)200928(10)162240, (01)00880304447172(17)200928(10)162250, (01)00880304447172(17)201028(10)700500, (01)00880304447172(17)201228(10)186490, (01)00880304447172(17)201228(10)377390, (01)00880304447172(17)210228(10)658100, (01)00880304447172(17)210228(10)658110, (01)00880304447172(17)210228(10)658120, (01)00880304447172(17)210228(10)658130, (01)00880304447172(17)210428(10)473170, (01)00880304447172(17)210628(10)912530, 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(01)00880304447172(17)250915(10)336630, (01)00880304447172(17)251207(10)152540, (01)00880304447172(17)251223(10)527470, (01)00880304447172(17)260113(10)647360, (01)00880304447172(17)260204(10)945690, (01)00880304447172(17)260211(10)057590, (01)00880304447172(17)260301(10)229330, (01)00880304447172(17)260411(10)759540, (01)00880304447172(17)260426(10)949860, (01)00880304447172(17)260523(10)258720, (01)00880304447172(17)260526(10)332610, (01)00880304447172(17)260711(10)787070, (01)00880304447172(17)260919(10)595080, (01)00880304447172(17)260916(10)595090, (01)00880304447172(17)270619(10)737830, (01)00880304447172(17)270618(10)737840, (01)00880304447172(17)270618(10)737850, (01)00880304447172(17)270619(10)755150, (01)00880304447172(17)270617(10)755160, (01)00880304447172(17)270617(10)755170, (01)00880304447172(17)270616(10)737860, (01)00880304447172(17)270625(10)755120, (01)00880304447172(17)270626(10)755130, (01)00880304447172(17)270624(10)755140, (01)00880304447172(17)270626(10)757300, (01)00880304447172(17)270630(10)202130, (01)00880304447172(17)270629(10)202460, (01)00880304447172(17)220101(10)733920R, (01)00880304447172(17)220101(10)733910R, (01)00880304447172(17)270825(10)732040, (01)00880304447172(17)271127(10)118130, (01)00880304447172(17)220401(10)416640R, (01)00880304447172(17)280223(10)141060, (01)00880304447172(17)280301(10)141040, (01)00880304447172(17)280228(10)378370, (01)00880304447172(17)280228(10)378390, (01)00880304447172(17)280322(10)765990, (01)00880304447172(17)280322(10)766020, (01)00880304447172(17)280323(10)766030, (01)00880304447172(17)280322(10)766050, (01)00880304447172(17)280328(10)766060, (01)00880304447172(17)280417(10)043910, (01)00880304447172(17)280417(10)921310, (01)00880304447172(17)280420(10)766080, (01)00880304447172(17)280508(10)234700, (01)00880304447172(17)280508(10)234710, (01)00880304447172(17)210401(10)473170R, (01)00880304447172(17)280516(10)350740, (01)00880304447172(17)280516(10)350940, (01)00880304447172(17)221001(10)658620R, (01)00880304447172(17)290205(10)347850, (01)00880304447172(17)290206(10)347840, (01)00880304447172(17)290207(10)347980, (01)00880304447172(17)290222(10)347830, (01)00880304447172(17)250209(10)157440R, (01)00880304447172(17)290403(10)318670, (01)00880304447172(17)290403(10)337700, (01)00880304447172(17)290405(10)318660, (01)00880304447172(17)290405(10)318680, (01)00880304447172(17)290404(10)318690, (01)00880304447172(17)290408(10)318860, (01)00880304447172(17)290404(10)337580, (01)00880304447172(17)290404(10)337650, (01)00880304447172(17)290404(10)337660, (01)00880304447172(17)290408(10)350360, (01)00880304447172(17)290409(10)350370, (01)00880304447172(17)290409(10)350390, (01)00880304447172(17)290409(10)350540, (01)00880304447172(17)290409(10)350560, (01)00880304447172(17)290409(10)318850, (01)00880304447172(17)290412(10)337460, (01)00880304447172(17)290412(10)337500, (01)00880304447172(17)290409(10)350380, (01)00880304447172(17)290410(10)350550, (01)00880304447172(17)290422(10)383600, (01)00880304447172(17)290421(10)383610, (01)00880304447172(17)290430(10)383630, (01)00880304447172(17)290506(10)337470, (01)00880304447172(17)240516(10)070900R, (01)00880304447172(17)260204(10)945690R 945690R.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 19 of 33

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.

Z-1656-2020
Recall number
Z-1656-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 919110, 191510, 414530, 650030, 931530, 836760, 836740, 162280, 162260, 285580, 285590, 668840, 036370, 390550, 613860, 518830, 555610, 207250, 913770, 628380, 286980, 336640, 057600, 143950, 329700, 115650, 737870, 732050, 191510R, 836740R, 118030, 302380, 302480, 378190, 766220, 021750, 021730, 921330, 162260R, 386330, 386300, 399990, 417210, 417220, 337710, 118030R,***UDI Numbers*** (01)00880304447158(17)190128(10)919110, (01)00880304447158(17)190201(10)191510, (01)00880304447158(17)191028(10)414530, (01)00880304447158(17)191001(10)650030, (01)00880304447158(17)191228(10)931530, (01)00880304447158(17)200328(10)836760, (01)00880304447158(17)200301(10)836740, (01)00880304447158(17)200828(10)162280, (01)00880304447158(17)200928(10)162260, (01)00880304447158(17)210328(10)285580, (01)00880304447158(17)210428(10)285590, (01)00880304447158(17)210928(10)668840, (01)00880304447158(17)221203(10)036370, (01)00880304447158(17)230821(10)390550, (01)00880304447158(17)230919(10)613860, (01)00880304447158(17)231209(10)518830, (01)00880304447158(17)231212(10)555610, (01)00880304447158(17)240518(10)207250, (01)00880304447158(17)241014(10)913770, (01)00880304447158(17)250325(10)628380, (01)00880304447158(17)250901(10)286980, (01)00880304447158(17)250914(10)336640, (01)00880304447158(17)260210(10)057600, (01)00880304447158(17)260510(10)143950, (01)00880304447158(17)260818(10)329700, (01)00880304447158(17)270627(10)115650, (01)00880304447158(17)270627(10)737870, (01)00880304447158(17)270825(10)732050, (01)00880304447158(17)190201(10)191510R, (01)00880304447158(17)200301(10)836740R, (01)00880304447158(17)271127(10)118030, (01)00880304447158(17)280301(10)302380, (01)00880304447158(17)280301(10)302480, (01)00880304447158(17)280315(10)378190, (01)00880304447158(17)280322(10)766220, (01)00880304447158(17)280417(10)021750, (01)00880304447158(17)280420(10)021730, (01)00880304447158(17)280430(10)921330, (01)00880304447158(17)200901(10)162260R, (01)00880304447158(17)290206(10)386330, (01)00880304447158(17)290206(10)386300, (01)00880304447158(17)290421(10)399990, (01)00880304447158(17)290421(10)417210, (01)00880304447158(17)290422(10)417220, (01)00880304447158(17)290430(10)337710, (01)00880304447158(17)271127(10)118030R, (01)00880304447158(17)270825(10)732050R 732050R.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 20 of 33

BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

Z-1657-2020
Recall number
Z-1657-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 860650, 215420, 555520, 583840, 089450, 283340, 132840, 413160, 058040, 181870, 408950, 409050, 409080, 851260, 234340, 338950, 581670, 201250, 518970, 024030, 030980, 166060, 219540, 219550, 219570, 429550, 296820, 296830, 296840, 296850, 298770, 041360, 041370, 041380, 146580, 146590, 443590, 844530, 115350, 251890, 326910, 630420, 870230, 389150, 572890, 698780, 970100, 199840, 481720, 398100, 398130, 789650, 789640, 877250, 202480, 202490, 398090, 398080, 398100R, 789650R, 256430, 256450, 256440, 323790, 398090R, 398130R, 630420R, 789640R, 349500, 710600, 846440, 846420, 846490, 915380, 915370, 962800, 122840, 995670, 995680, 592030, 467400, 467410, 467420, 736490, 073190, 372270, 107950, 186460, 277550. ***UDI Numbers*** (01)00880304551107(17)141007(10)860650, (01)00880304551107(17)141112(10)215420, (01)00880304551107(17)181231(10)555520, (01)00880304551107(17)181231(10)583840, (01)00880304551107(17)190206(10)089450, (01)00880304551107(17)190221(10)283340, (01)00880304551107(17)190505(10)132840, (01)00880304551107(17)190530(10)413160, (01)00880304551107(17)190725(10)058040, (01)00880304551107(17)190805(10)181870, (01)00880304551107(17)190826(10)408950, (01)00880304551107(17)190826(10)409050, (01)00880304551107(17)190826(10)409080, (01)00880304551107(17)190930(10)851260, (01)00880304551107(17)191104(10)234340, (01)00880304551107(17)191111(10)338950, (01)00880304551107(17)191209(10)581670, (01)00880304551107(17)200318(10)201250, (01)00880304551107(17)200331(10)518970, (01)00880304551107(17)200430(10)024030, (01)00880304551107(17)200501(10)030980, (01)00880304551107(17)200515(10)166060, (01)00880304551107(17)200521(10)219540, (01)00880304551107(17)200522(10)219550, (01)00880304551107(17)200522(10)219570, (01)00880304551107(17)200611(10)429550, (01)00880304551107(17)200901(10)296820, (01)00880304551107(17)200901(10)296830, (01)00880304551107(17)200901(10)296840, (01)00880304551107(17)200901(10)296850, (01)00880304551107(17)200902(10)298770, (01)00880304551107(17)201109(10)041360, (01)00880304551107(17)201110(10)041370, (01)00880304551107(17)201109(10)041380, (01)00880304551107(17)201119(10)146580, (01)00880304551107(17)201119(10)146590, (01)00880304551107(17)201218(10)443590, (01)00880304551107(17)210126(10)844530, (01)00880304551107(17)210217(10)115350, (01)00880304551107(17)210227(10)251890, (01)00880304551107(17)210307(10)326910, (01)00880304551107(17)210330(10)630420, (01)00880304551107(17)210419(10)870230, (01)00880304551107(17)210606(10)389150, (01)00880304551107(17)210622(10)572890, (01)00880304551107(17)210701(10)698780, (01)00880304551107(17)210725(10)970100, (01)00880304551107(17)210808(10)199840, (01)00880304551107(17)210908(10)481720, (01)00880304551107(17)220523(10)398100, (01)00880304551107(17)220603(10)398130, (01)00880304551107(17)220603(10)789650, (01)00880304551107(17)220611(10)789640, (01)00880304551107(17)220608(10)877250, (01)00880304551107(17)220630(10)202480, (01)00880304551107(17)220630(10)202490, (01)00880304551107(17)220823(10)398090, (01)00880304551107(17)220825(10)398080, (01)00880304551107(17)220523(10)398100R, (01)00880304551107(17)220603(10)789650R, (01)00880304551107(17)230216(10)256430, (01)00880304551107(17)230221(10)256450, (01)00880304551107(17)230228(10)256440, (01)00880304551107(17)230228(10)323790, (01)00880304551107(17)220823(10)398090R, (01)00880304551107(17)220603(10)398130R, (01)00880304551107(17)210330(10)630420R, (01)00880304551107(17)220611(10)789640R, (01)00880304551107(17)240205(10)349500, (01)00880304551107(17)240228(10)710600, (01)00880304551107(17)240306(10)846440, (01)00880304551107(17)240309(10)846420, (01)00880304551107(17)240309(10)846490, (01)00880304551107(17)240313(10)915380, (01)00880304551107(17)240314(10)915370, (01)00880304551107(17)240317(10)962800, (01)00880304551107(17)240323(10)122840, (01)00880304551107(17)240321(10)995670, (01)00880304551107(17)240321(10)995680, (01)00880304551107(17)240628(10)592030, (01)00880304551107(17)240915(10)467400, (01)00880304551107(17)240914(10)467410, (01)00880304551107(17)240913(10)467420, (01)00880304551107(17)240926(10)736490, (01)00880304551107(17)241009(10)073190, (01)00880304551107(17)241209(10)372270, (01)00880304551107(17)250116(10)107950, (01)00880304551107(17)250123(10)186460, (01)00880304551107(17)250123(10)277550

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 21 of 33

BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

Z-1658-2020
Recall number
Z-1658-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 860710, 215430, 555230, 583850, 089660, 283370, 132850, 372710, 372760, 181880, 357230, 409110, 409190, 765360, 196690, 196700, 196710, 338960, 511930, 549800, 706840, 386790, 445290, 723200, 024040, 079210, 262220, 262230, 429560, 821040, 821050, 960990, 039770, 399430, 429450, 583060, 776890, 938560, 245080, 245090, 303380, 443600, 892230, 751870, 115420, 186520, 326920, 513020, 665290, 978020, 225130, 424200, 572910, 698790, 932210, 637420, 637430, 637440, 398110, 398120, 398140, 398150, 398160, 789690, 789700, 789670, 877260, 202510, 583060R, 572910R, 877260R, 398160R, 202500, 809040, 747440, 916120, 916130, 916140, 916150, 549800R, 349510, 349530, 349520, 710630, 710610, 846580, 846670, 846740, 895240, 915400, 963760, 996210, 996220, 713910, 980630, 094950, 094960, 094980, 455060, 705090, 798220, 325450, 250110, 255770, 250120, 350890, 541430. ***UDI Numbers*** (01)00880304551015(17)141007(10)860710, (01)00880304551015(17)141112(10)215430, (01)00880304551015(17)181231(10)555230, (01)00880304551015(17)181231(10)583850, (01)00880304551015(17)190209(10)089660, (01)00880304551015(17)190313(10)283370, (01)00880304551015(17)190505(10)132850, (01)00880304551015(17)190527(10)372710, (01)00880304551015(17)190527(10)372760, (01)00880304551015(17)190805(10)181880, (01)00880304551015(17)190819(10)357230, (01)00880304551015(17)190826(10)409110, (01)00880304551015(17)190826(10)409190, (01)00880304551015(17)190923(10)765360, (01)00880304551015(17)191103(10)196690, (01)00880304551015(17)191103(10)196700, (01)00880304551015(17)191103(10)196710, (01)00880304551015(17)191111(10)338960, (01)00880304551015(17)191201(10)511930, (01)00880304551015(17)191215(10)549800, (01)00880304551015(17)191229(10)706840, (01)00880304551015(17)200316(10)386790, (01)00880304551015(17)200414(10)445290, (01)00880304551015(17)200413(10)723200, (01)00880304551015(17)200505(10)024040, (01)00880304551015(17)200514(10)079210, (01)00880304551015(17)200527(10)262220, (01)00880304551015(17)200527(10)262230, (01)00880304551015(17)200611(10)429560, (01)00880304551015(17)200725(10)821040, (01)00880304551015(17)200728(10)821050, (01)00880304551015(17)200730(10)960990, (01)00880304551015(17)200807(10)039770, (01)00880304551015(17)200928(10)399430, (01)00880304551015(17)200928(10)429450, (01)00880304551015(17)201001(10)583060, (01)00880304551015(17)201019(10)776890, (01)00880304551015(17)201106(10)938560, (01)00880304551015(17)201130(10)245080, (01)00880304551015(17)201201(10)245090, (01)00880304551015(17)201207(10)303380, (01)00880304551015(17)201218(10)443600, (01)00880304551015(17)210126(10)892230, (01)00880304551015(17)210114(10)751870, (01)00880304551015(17)210217(10)115420, (01)00880304551015(17)210224(10)186520, (01)00880304551015(17)210307(10)326920, (01)00880304551015(17)210323(10)513020, (01)00880304551015(17)210407(10)665290, (01)00880304551015(17)210427(10)978020, (01)00880304551015(17)210524(10)225130, (01)00880304551015(17)210607(10)424200, (01)00880304551015(17)210701(10)572910, (01)00880304551015(17)210705(10)698790, (01)00880304551015(17)210720(10)932210, (01)00880304551015(17)210919(10)637420, (01)00880304551015(17)210920(10)637430, (01)00880304551015(17)210920(10)637440, (01)00880304551015(17)220519(10)398110, (01)00880304551015(17)220518(10)398120, (01)00880304551015(17)220517(10)398140, (01)00880304551015(17)220519(10)398150, (01)00880304551015(17)220603(10)398160, (01)00880304551015(17)220603(10)789690, (01)00880304551015(17)220603(10)789700, (01)00880304551015(17)220608(10)789670, (01)00880304551015(17)220613(10)877260, (01)00880304551015(17)220701(10)202510, (01)00880304551015(17)201001(10)583060R, (01)00880304551015(17)210701(10)572910R, (01)00880304551015(17)220613(10)877260R, (01)00880304551015(17)220603(10)398160R, (01)00880304551015(17)221107(10)202500, (01)00880304551015(17)221103(10)809040, (01)00880304551015(17)230116(10)747440, (01)00880304551015(17)230204(10)916120, (01)00880304551015(17)230206(10)916130, (01)00880304551015(17)230204(10)916140, (01)00880304551015(17)230202(10)916150, (01)00880304551015(17)191215(10)549800R, (01)00880304551015(17)240205(10)349510, (01)00880304551015(17)240204(10)349530, (01)00880304551015(17)240211(10)349520, (01)00880304551015(17)240228(10)710630, (01)00880304551015(17)240308(10)710610, (01)00880304551015(17)240309(10)846580, (01)00880304551015(17)240311(10)846670, (01)00880304551015(17)240310(10)846740, (01)00880304551015(17)240315(10)895240, (01)00880304551015(17)240323(10)915400, (01)00880304551015(17)240320(10)963760, (01)00880304551015(17)240323(10)996210, (01)00880304551015(17)240323(10)996220, (01)00880304551015(17)240302(10)713910, (01)00880304551015(17)240515(10)980630, (01)00880304551015(17)240731(10)094950, (01)00880304551015(17)240731(10)094960, (01)00880304551015(17)240731(10)094980, (01)00880304551015(17)240622(10)455060, (01)00880304551015(17)240712(10)705090, (01)00880304551015(17)240801(10)798220, (01)00880304551015(17)240817(10)325450, (01)00880304551015(17)241009(10)250110, (01)00880304551015(17)241009(10)255770, (01)00880304551015(17)241023(10)250120, (01)00880304551015(17)241023(10)350890, (01)00880304551015(17)241110(10)541430

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 22 of 33

BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

Z-1659-2020
Recall number
Z-1659-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 860790, 215440, 381650, 555570, 089680, 283390, 509720, 657620, 132830, 372720, 097250, 281740, 409230, 409310, 409330, 196720, 196730, 338940, 452050, 581680, 776930, 386800, 233600, 079220, 204510, 262240, 429580, 595980, 849850, 849760, 041390, 041400, 041410, 041420, 041430, 245100, 245110, 245120, 245130, 779360, 915810, 115430, 152270, 326930, 441890, 665300, 924180, 009460, 169730, 389160, 424210, 723180, 723190, 743960, 199850, 970110, 390630, 732410, 398180, 398230, 398190, 398210, 398220, 789770, 789720, 789810, 877270, 202530, 789770R, 789810R, 202530R, 398190R, 674330, 674370, 809050, 325580, 916160, 916170, 916180, 916200, 219810, 398230R, 789720R, 349550, 349560, 349540, 710640, 710650, 846810, 713920, 847000, 847030, 847050, 847140, 846860, 847160, 399490, 399500, 417030, 417010, 417020, 073050, 455050, 704980, 799220, 838250, 918280, 532640, 532660, 028890, 585150, 525420,***UDI Numbers*** (01)00880304551091(17)141007(10)860790, (01)00880304551091(17)141112(10)215440, (01)00880304551091(17)181130(10)381650, (01)00880304551091(17)181231(10)555570, (01)00880304551091(17)190213(10)089680, (01)00880304551091(17)190225(10)283390, (01)00880304551091(17)190320(10)509720, (01)00880304551091(17)190331(10)657620, (01)00880304551091(17)190505(10)132830, (01)00880304551091(17)190528(10)372720, (01)00880304551091(17)190731(10)097250, (01)00880304551091(17)190818(10)281740, (01)00880304551091(17)190826(10)409230, (01)00880304551091(17)190826(10)409310, (01)00880304551091(17)190826(10)409330, (01)00880304551091(17)191103(10)196720, (01)00880304551091(17)191103(10)196730, (01)00880304551091(17)191111(10)338940, (01)00880304551091(17)191119(10)452050, (01)00880304551091(17)191209(10)581680, (01)00880304551091(17)191223(10)776930, (01)00880304551091(17)200314(10)386800, (01)00880304551091(17)200330(10)233600, (01)00880304551091(17)200512(10)079220, (01)00880304551091(17)200521(10)204510, (01)00880304551091(17)200522(10)262240, (01)00880304551091(17)200610(10)429580, (01)00880304551091(17)200706(10)595980, (01)00880304551091(17)200725(10)849850, (01)00880304551091(17)200727(10)849760, (01)00880304551091(17)201111(10)041390, (01)00880304551091(17)201111(10)041400, (01)00880304551091(17)201111(10)041410, (01)00880304551091(17)201110(10)041420, (01)00880304551091(17)201111(10)041430, (01)00880304551091(17)201130(10)245100, (01)00880304551091(17)201130(10)245110, (01)00880304551091(17)201130(10)245120, (01)00880304551091(17)201130(10)245130, (01)00880304551091(17)210119(10)779360, (01)00880304551091(17)210201(10)915810, (01)00880304551091(17)210217(10)115430, (01)00880304551091(17)210224(10)152270, (01)00880304551091(17)210307(10)326930, (01)00880304551091(17)210321(10)441890, (01)00880304551091(17)210407(10)665300, (01)00880304551091(17)210425(10)924180, (01)00880304551091(17)210503(10)009460, (01)00880304551091(17)210517(10)169730, (01)00880304551091(17)210603(10)389160, (01)00880304551091(17)210606(10)424210, (01)00880304551091(17)210705(10)723180, (01)00880304551091(17)210705(10)723190, (01)00880304551091(17)210711(10)743960, (01)00880304551091(17)210808(10)199850, (01)00880304551091(17)210803(10)970110, (01)00880304551091(17)210831(10)390630, (01)00880304551091(17)210929(10)732410, (01)00880304551091(17)220518(10)398180, (01)00880304551091(17)220523(10)398230, (01)00880304551091(17)220523(10)398190, (01)00880304551091(17)220603(10)398210, (01)00880304551091(17)220603(10)398220, (01)00880304551091(17)220601(10)789770, (01)00880304551091(17)220612(10)789720, (01)00880304551091(17)220611(10)789810, (01)00880304551091(17)220608(10)877270, (01)00880304551091(17)220701(10)202530, (01)00880304551091(17)220601(10)789770R, (01)00880304551091(17)220611(10)789810R, (01)00880304551091(17)220701(10)202530R, (01)00880304551091(17)220523(10)398190R, (01)00880304551091(17)221018(10)674330, (01)00880304551091(17)221018(10)674370, (01)00880304551091(17)221106(10)809050, (01)00880304551091(17)221211(10)325580, (01)00880304551091(17)230205(10)916160, (01)00880304551091(17)230204(10)916170, (01)00880304551091(17)230205(10)916180, (01)00880304551091(17)230206(10)916200, (01)00880304551091(17)230330(10)219810, (01)00880304551091(17)220523(10)398230R, (01)00880304551091(17)220612(10)789720R, (01)00880304551091(17)240203(10)349550, (01)00880304551091(17)240205(10)349560, (01)00880304551091(17)240210(10)349540, (01)00880304551091(17)240306(10)710640, (01)00880304551091(17)240228(10)710650, (01)00880304551091(17)240307(10)846810, (01)00880304551091(17)240308(10)713920, (01)00880304551091(17)240307(10)847000, (01)00880304551091(17)240307(10)847030, (01)00880304551091(17)240313(10)847050, (01)00880304551091(17)240309(10)847140, (01)00880304551091(17)240314(10)846860, (01)00880304551091(17)240326(10)847160, (01)00880304551091(17)240416(10)399490, (01)00880304551091(17)240416(10)399500, (01)00880304551091(17)240501(10)417030, (01)00880304551091(17)240502(10)417010, (01)00880304551091(17)240502(10)417020, (01)00880304551091(17)240621(10)073050, (01)00880304551091(17)240628(10)455050, (01)00880304551091(17)240802(10)704980, (01)00880304551091(17)240802(10)799220, (01)00880304551091(17)240801(10)838250, (01)00880304551091(17)240731(10)918280, (01)00880304551091(17)240912(10)532640, (01)00880304551091(17)240912(10)532660, (01)00880304551091(17)241008(10)028890, (01)00880304551091(17)241110(10)585150, (01)00880304551091(17)241109(10)525420, (01)00880304551091(17)220603(10)398210R 398210R.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 23 of 33

BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

Z-1660-2020
Recall number
Z-1660-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 860910, 215450, 555580, 583860, 089700, 102920, 283420, 148680, 503890, 954890, 097260, 325340, 409370, 409450, 409490, 851280, 234350, 452060, 706850, 257410, 709790, 967440, 079230, 262250, 458790, 728540, 172680, 533270, 776910, 020620, 196040, 526700, 751880, 988270, 115360, 282070, 410360, 908940, 978030, 978040, 313260, 313270, 089530, 089540, 637400, 637410, 685000, 398240, 398250, 398280, 398260, 877310, 877320, 877330, 202540, 398260R, 555580R, 398240R, 674430, 809060, 747370, 916210, 916220, 262250R, 877320R, 349570, 914620, 914630, 962810, 963780, 005670, 035060, 399640, 399660, 399670, 399680, 417040, 417060, 417070, 308170, 705200, 694850, 736560, 372280, 064920, 637410R, 186470. ***UDI Numbers*** (01)00880304551008(17)141007(10)860910, (01)00880304551008(17)141112(10)215450, (01)00880304551008(17)181231(10)555580, (01)00880304551008(17)181231(10)583860, (01)00880304551008(17)190206(10)089700, (01)00880304551008(17)190215(10)102920, (01)00880304551008(17)190319(10)283420, (01)00880304551008(17)190609(10)148680, (01)00880304551008(17)190609(10)503890, (01)00880304551008(17)190721(10)954890, (01)00880304551008(17)190731(10)097260, (01)00880304551008(17)190815(10)325340, (01)00880304551008(17)190826(10)409370, (01)00880304551008(17)190826(10)409450, (01)00880304551008(17)190826(10)409490, (01)00880304551008(17)190930(10)851280, (01)00880304551008(17)191104(10)234350, (01)00880304551008(17)191119(10)452060, (01)00880304551008(17)191223(10)706850, (01)00880304551008(17)200323(10)257410, (01)00880304551008(17)200403(10)709790, (01)00880304551008(17)200428(10)967440, (01)00880304551008(17)200507(10)079230, (01)00880304551008(17)200525(10)262250, (01)00880304551008(17)200612(10)458790, (01)00880304551008(17)200711(10)728540, (01)00880304551008(17)200824(10)172680, (01)00880304551008(17)200928(10)533270, (01)00880304551008(17)201019(10)776910, (01)00880304551008(17)201111(10)020620, (01)00880304551008(17)201201(10)196040, (01)00880304551008(17)201223(10)526700, (01)00880304551008(17)210118(10)751880, (01)00880304551008(17)210208(10)988270, (01)00880304551008(17)210217(10)115360, (01)00880304551008(17)210302(10)282070, (01)00880304551008(17)210315(10)410360, (01)00880304551008(17)210425(10)908940, (01)00880304551008(17)210427(10)978030, (01)00880304551008(17)210427(10)978040, (01)00880304551008(17)210527(10)313260, (01)00880304551008(17)210527(10)313270, (01)00880304551008(17)210801(10)089530, (01)00880304551008(17)210801(10)089540, (01)00880304551008(17)210919(10)637400, (01)00880304551008(17)210920(10)637410, (01)00880304551008(17)211123(10)685000, (01)00880304551008(17)220518(10)398240, (01)00880304551008(17)220518(10)398250, (01)00880304551008(17)220518(10)398280, (01)00880304551008(17)220527(10)398260, (01)00880304551008(17)220608(10)877310, (01)00880304551008(17)220608(10)877320, (01)00880304551008(17)220608(10)877330, (01)00880304551008(17)220630(10)202540, (01)00880304551008(17)220527(10)398260R, (01)00880304551008(17)181202(10)555580R, (01)00880304551008(17)220518(10)398240R, (01)00880304551008(17)221018(10)674430, (01)00880304551008(17)221103(10)809060, (01)00880304551008(17)230116(10)747370, (01)00880304551008(17)230201(10)916210, (01)00880304551008(17)230204(10)916220, (01)00880304551008(17)200525(10)262250R, (01)00880304551008(17)220608(10)877320R, (01)00880304551008(17)240205(10)349570, (01)00880304551008(17)240316(10)914620, (01)00880304551008(17)240317(10)914630, (01)00880304551008(17)240316(10)962810, (01)00880304551008(17)240314(10)963780, (01)00880304551008(17)240320(10)005670, (01)00880304551008(17)240323(10)035060, (01)00880304551008(17)240416(10)399640, (01)00880304551008(17)240416(10)399660, (01)00880304551008(17)240416(10)399670, (01)00880304551008(17)240416(10)399680, (01)00880304551008(17)240502(10)417040, (01)00880304551008(17)240502(10)417060, (01)00880304551008(17)240502(10)417070, (01)00880304551008(17)240819(10)308170, (01)00880304551008(17)240905(10)705200, (01)00880304551008(17)240912(10)694850, (01)00880304551008(17)240926(10)736560, (01)00880304551008(17)241024(10)372280, (01)00880304551008(17)241218(10)064920, (01)00880304551008(17)210920(10)637410R, (01)00880304551008(17)250113(10)186470

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 24 of 33

BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

Z-1661-2020
Recall number
Z-1661-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 860990, 215460, 555600, 583870, 089720, 283410, 657770, 148690, 412910, 181860, 357240, 409510, 409570, 196740, 234330, 338970, 816850, 723210, 262260, 039780, 399440, 399450, 776900, 303400, 587270, 988280, 152280, 481410, 817140, 817150, 096260, 313250, 723230, 723240, 429710, 429720, 637380, 398290, 398310, 789830, 877380, 817140R, 972000, 971990, 637380R, 776900R, 809120, 583870R, 398290R, 096260R, 398310R, 915410, 914640, 914650, 963790, 962850, 995720, 995760, 153910, 153920, 277690, 277720, 277750, 484740, 723360, 197930, 736570. ***UDI Numbers*** (01)00880304551114(17)141007(10)860990, (01)00880304551114(17)141112(10)215460, (01)00880304551114(17)181202(10)555600, (01)00880304551114(17)181231(10)583870, (01)00880304551114(17)190206(10)089720, (01)00880304551114(17)190319(10)283410, (01)00880304551114(17)190327(10)657770, (01)00880304551114(17)190609(10)148690, (01)00880304551114(17)190624(10)412910, (01)00880304551114(17)190805(10)181860, (01)00880304551114(17)190819(10)357240, (01)00880304551114(17)190826(10)409510, (01)00880304551114(17)190826(10)409570, (01)00880304551114(17)191104(10)196740, (01)00880304551114(17)191103(10)234330, (01)00880304551114(17)191111(10)338970, (01)00880304551114(17)200121(10)816850, (01)00880304551114(17)200403(10)723210, (01)00880304551114(17)200522(10)262260, (01)00880304551114(17)200806(10)039780, (01)00880304551114(17)200915(10)399440, (01)00880304551114(17)200915(10)399450, (01)00880304551114(17)201019(10)776900, (01)00880304551114(17)201207(10)303400, (01)00880304551114(17)210106(10)587270, (01)00880304551114(17)210208(10)988280, (01)00880304551114(17)210224(10)152280, (01)00880304551114(17)210321(10)481410, (01)00880304551114(17)210418(10)817140, (01)00880304551114(17)210417(10)817150, (01)00880304551114(17)210506(10)096260, (01)00880304551114(17)210527(10)313250, (01)00880304551114(17)210701(10)723230, (01)00880304551114(17)210701(10)723240, (01)00880304551114(17)210831(10)429710, (01)00880304551114(17)210831(10)429720, (01)00880304551114(17)210920(10)637380, (01)00880304551114(17)220518(10)398290, (01)00880304551114(17)220518(10)398310, (01)00880304551114(17)220603(10)789830, (01)00880304551114(17)220608(10)877380, (01)00880304551114(17)210418(10)817140R, (01)00880304551114(17)220825(10)972000, (01)00880304551114(17)220906(10)971990, (01)00880304551114(17)210920(10)637380R, (01)00880304551114(17)201019(10)776900R, (01)00880304551114(17)221107(10)809120, (01)00880304551114(17)181202(10)583870R, (01)00880304551114(17)220518(10)398290R, (01)00880304551114(17)210506(10)096260R, (01)00880304551114(17)220518(10)398310R, (01)00880304551114(17)240313(10)915410, (01)00880304551114(17)240314(10)914640, (01)00880304551114(17)240314(10)914650, (01)00880304551114(17)240314(10)963790, (01)00880304551114(17)240321(10)962850, (01)00880304551114(17)240321(10)995720, (01)00880304551114(17)240321(10)995760, (01)00880304551114(17)240402(10)153910, (01)00880304551114(17)240402(10)153920, (01)00880304551114(17)240402(10)277690, (01)00880304551114(17)240402(10)277720, (01)00880304551114(17)240402(10)277750, (01)00880304551114(17)241024(10)484740, (01)00880304551114(17)241107(10)723360, (01)00880304551114(17)250113(10)197930, (01)00880304551114(17)241009(10)736570

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 25 of 33

BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

Z-1662-2020
Recall number
Z-1662-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 584770, 095850, 095860, 095870, 096040, 096050, 096060, 096070, 096090, 096100, 096110, 095840, 096080, 318760, 527220, 527230, 600510, 688300, 793160, 857810, 976910, 976920, 976930, 977090, 977120, 977140, 074610, 239220, 074780, 239230, 310060, 367680, 496380, 496390, 496530, 680250, 702440, 702450, 782830, 782840, 791540, 830290, 830300, 926390, 136880, 177480, 247430, 272140, 309960, 413070, 425610, 459560, 478190, 545150, 545160, 586670, 613870, 667590, 667600, 685310, 685320, 772880, 969470, 010200, 010210, 088220, 170070, 242890, 294830, 330870, 330880, 428820, 428830, 447500, 461650, 499260, 531400, 555660, 596820, 899170, 090900, 156130, 252760, 252770, 411570, 411580, 434390, 434400, 434410, 509760, 509770, 567540, 567530, 620020, 722630, 722640, 803100, 898730, 942660, 007820, 007830, 108310, 132860, 171390, 257290, 428210, 548490, 548500, 588740, 628700, 628710, 689300, 771070, 907630, 907670, 097280, 274100, 274170, 325460, 369000, 411250, 579780, 579790, 625540, 643570, 659400, 659410, 731730, 745520, 745530, 858340, 270810, 270820, 280950, 280960, 280970, 280980, 280990, 392970, 392890, 458180, 535670, 535760, 615720, 617670, 617680, 702350, 863530, 863540, 993760, 993850, 993750, 089250, 232340, 232360, 958700, 492450, 492460, 492470, 569520, 569530, 738940, 739010, 745850, 845060, 900820, 981510, 046290, 046300, 981430, 126260, 212220, 126250, 212080, 212200, 314670, 361070, 731540, 731550, 731560, 731570, 731580, 807270, 807200, 866310, 913310, 913320, 913330, 913420, 047250, 131950, 225950, 226000, 316480, 316490, 372260, 428590, 374890, 611530, 611550, 611560, 679570, 776840, 788220, 971680, 971700, 045950, 045970, 166140, 166130, 364320, 317530, 317540, 317550, 525780, 525790, 525900, 697630, 697680, 835990, 922910, 923000, 922920, 046980, 046990, 047000, 210220, 210140, 210150, 351670, 351590, 500900, 500910, 500760, 555110, 675040, 675050, 806790, 806810, 806820, 955850, 081790, 136100, 136120, 136130, 136140, 192840, 192850, 486300, 486360, 486370, 588100, 588160, 729660, 729640, 729650, 903260, 931790, 931800, 931810, 004830, 088130, 225980, 432590, 432610, 432620, 432630, 594290, 582710, 582750, 598560, 598570, 598590, 598600, 598610, 598660, 598670, 598690, 653940, 653950, 653960, 582690, 582740, 600850, 600860, 600870, 600880, 600890, 600900, 653980, 653990, 654000, 654020, 654030, 654040, 654050, 654070, 654080, 667540, 667550, 667560, 667570, 667610, 667620, 667630, 667640, 667650, 667690, 789850, 789860, 789880, 789940, 789980, 789990, 790000, 861730, 861750, 861770, 877400, 877370, 877390, 877420, 520420, 520430, 520440, 520450, 520460, 520470, 520480, 594280, 633680, 633650, 674440, 674450, 674470, 809130, 809140, 177560, 177580, 325640, 437600, 437570, 618620, 618610, 747000, 747020, 747240, 747250, 916260, 916270, 916280, 916330, 916290, 877400R, 325620, 766460, 766540, 766560, 921370, 921390, 921410, 043720, 043620, 043660, 043670, 043690, 043710, 234810, 234820, 234840, 294560, 294570, 294580, 294600, 294620, 294630, 294660, 294670, 294680, 294700, 294710, 294720, 319270, 319280, 319310, 319330, 319360, 319380, 319400, 319410, 294550, 294610, 294690, 319370, 699410, 699430, 699440, 709370, 709450, 713930, 713940, 844500, 294650, 709820, 709830, 711890, 711910, 711920, 712000, 790940, 818410, 818420, 844490, 844520, 844530, 845240, 851670, 879140, 879150, 879160, 879830, 894690, 894910, 035400, 035500, 790930, 879820, 894680, 894700, 894920, 894930, 915440, 915450, 961650, 964710, 964720, 995130, 995240, 995250, 996380, 035380, 035420, 035470, 035490, 153850, 231530, 232080, 245440, 995120, 996350, 996360, 996370, 153840, 153860, 153870, 170980, 170990, 171000, 171020, 200760, 200790, 200830, 200850, 200880, 231510, 231520, 231960, 232000, 232030, 232040, 232060, 232090, 232100, 245450, 245460, 245470, 245480, 245490, 245500, 245510, 245520, 259250,***UDI Numbers*** (01)00880304001831(17)221028(10)584770, (01)00880304001831(17)221202(10)095850, (01)00880304001831(17)221206(10)095860, (01)00880304001831(17)221207(10)095870, (01)00880304001831(17)221205(10)096040, (01)00880304001831(17)221203(10)096050, (01)00880304001831(17)221206(10)096060, (01)00880304001831(17)221206(10)096070, (01)00880304001831(17)221202(10)096090, (01)00880304001831(17)221206(10)096100, (01)00880304001831(17)221204(10)096110, (01)00880304001831(17)221212(10)095840, (01)00880304001831(17)221212(10)096080, (01)00880304001831(17)230114(10)318760, (01)00880304001831(17)230118(10)527220, (01)00880304001831(17)230118(10)527230, (01)00880304001831(17)230129(10)600510, (01)00880304001831(17)230212(10)688300, (01)00880304001831(17)230215(10)793160, (01)00880304001831(17)230228(10)857810, (01)00880304001831(17)230312(10)976910, (01)00880304001831(17)230314(10)976920, (01)00880304001831(17)230311(10)976930, (01)00880304001831(17)230311(10)977090, (01)00880304001831(17)230311(10)977120, (01)00880304001831(17)230312(10)977140, (01)00880304001831(17)230326(10)074610, (01)00880304001831(17)230419(10)239220, (01)00880304001831(17)230422(10)074780, (01)00880304001831(17)230422(10)239230, (01)00880304001831(17)230419(10)310060, (01)00880304001831(17)230426(10)367680, (01)00880304001831(17)230516(10)496380, (01)00880304001831(17)230517(10)496390, (01)00880304001831(17)230517(10)496530, (01)00880304001831(17)230612(10)680250, (01)00880304001831(17)230612(10)702440, (01)00880304001831(17)230612(10)702450, (01)00880304001831(17)230617(10)782830, (01)00880304001831(17)230617(10)782840, (01)00880304001831(17)230625(10)830290, (01)00880304001831(17)230625(10)830300, (01)00880304001831(17)230702(10)926390, (01)00880304001831(17)230725(10)136880, (01)00880304001831(17)230728(10)177480, (01)00880304001831(17)230807(10)247430, (01)00880304001831(17)230808(10)272140, (01)00880304001831(17)230813(10)309960, (01)00880304001831(17)230822(10)413070, (01)00880304001831(17)230823(10)425610, (01)00880304001831(17)230829(10)459560, (01)00880304001831(17)230903(10)478190, (01)00880304001831(17)230906(10)545150, (01)00880304001831(17)230907(10)545160, (01)00880304001831(17)230911(10)586670, (01)00880304001831(17)230916(10)613870, (01)00880304001831(17)230919(10)667590, (01)00880304001831(17)230919(10)667600, (01)00880304001831(17)230919(10)685310, (01)00880304001831(17)230920(10)685320, (01)00880304001831(17)230930(10)772880, (01)00880304001831(17)231021(10)969470, (01)00880304001831(17)231025(10)010200, (01)00880304001831(17)231026(10)010210, (01)00880304001831(17)231101(10)088220, (01)00880304001831(17)231109(10)170070, (01)00880304001831(17)231116(10)242890, (01)00880304001831(17)231120(10)294830, (01)00880304001831(17)231128(10)330870, (01)00880304001831(17)231120(10)330880, (01)00880304001831(17)231202(10)428820, (01)00880304001831(17)231202(10)428830, (01)00880304001831(17)231203(10)447500, (01)00880304001831(17)231204(10)461650, (01)00880304001831(17)231209(10)499260, (01)00880304001831(17)231212(10)531400, (01)00880304001831(17)231213(10)555660, (01)00880304001831(17)240102(10)596820, (01)00880304001831(17)240120(10)899170, (01)00880304001831(17)240211(10)090900, (01)00880304001831(17)240217(10)156130, (01)00880304001831(17)240219(10)252760, (01)00880304001831(17)240219(10)252770, (01)00880304001831(17)240310(10)411570, (01)00880304001831(17)240304(10)411580, (01)00880304001831(17)240309(10)434390, (01)00880304001831(17)240306(10)434400, (01)00880304001831(17)240305(10)434410, (01)00880304001831(17)240316(10)509760, (01)00880304001831(17)240316(10)509770, (01)00880304001831(17)240320(10)567540, (01)00880304001831(17)240326(10)567530, (01)00880304001831(17)240325(10)620020, (01)00880304001831(17)240402(10)722630, (01)00880304001831(17)240402(10)722640, (01)00880304001831(17)240407(10)803100, (01)00880304001831(17)240420(10)898730, (01)00880304001831(17)240420(10)942660, (01)00880304001831(17)240423(10)007820, (01)00880304001831(17)240423(10)007830, (01)00880304001831(17)240501(10)108310, (01)00880304001831(17)240504(10)132860, (01)00880304001831(17)240508(10)171390, (01)00880304001831(17)240519(10)257290, (01)00880304001831(17)240529(10)428210, (01)00880304001831(17)240610(10)548490, (01)00880304001831(17)240610(10)548500, (01)00880304001831(17)240612(10)588740, (01)00880304001831(17)240617(10)628700, (01)00880304001831(17)240618(10)628710, (01)00880304001831(17)240630(10)689300, (01)00880304001831(17)240707(10)771070, (01)00880304001831(17)240711(10)907630, (01)00880304001831(17)240713(10)907670, (01)00880304001831(17)240728(10)097280, (01)00880304001831(17)240814(10)274100, (01)00880304001831(17)240813(10)274170, (01)00880304001831(17)240814(10)325460, (01)00880304001831(17)240820(10)369000, (01)00880304001831(17)240826(10)411250, (01)00880304001831(17)240909(10)579780, (01)00880304001831(17)240910(10)579790, (01)00880304001831(17)240912(10)625540, (01)00880304001831(17)240912(10)643570, (01)00880304001831(17)240914(10)659400, (01)00880304001831(17)240915(10)659410, (01)00880304001831(17)240919(10)731730, 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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 26 of 33

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

Z-1663-2020
Recall number
Z-1663-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 410380, 036380, 095880, 095890, 095900, 096130, 096260, 096310, 096340, 096280, 242320, 242340, 242360, 318790, 527250, 527260, 527950, 527240, 527970, 527990, 688310, 793170, 857820, 857830, 864580, 864600, 864590, 976940, 976950, 977160, 074620, 074630, 074760, 310210, 145230, 239240, 239260, 239270, 239410, 239420, 310070, 310080, 310240, 310250, 367690, 496540, 496550, 496400, 680280, 680400, 680410, 702460, 702470, 749110, 749120, 791550, 791560, 844530, 902650, 914080, 025500, 085540, 136890, 219930, 219940, 272150, 272160, 272170, 324060, 413090, 413100, 413110, 459570, 478200, 518450, 545170, 562920, 601550, 613880, 667610, 685330, 685340, 685350, 747290, 772890, 898010, 910630, 945840, 969600, 985840, 123080, 123130, 123140, 139790, 139800, 139820, 201140, 242900, 242910, 310430, 330890, 330900, 413410, 447710, 447720, 461660, 486270, 499290, 518840, 802360, 802390, 899180, 090910, 156140, 252780, 252790, 998620, 411590, 434420, 434430, 450640, 509780, 567550, 567560, 620030, 634070, 722570, 722650, 722660, 803110, 803120, 898740, 942670, 007840, 007850, 108320, 108330, 171400, 237760, 257300, 372780, 372790, 428280, 428290, 548510, 588770, 628650, 628720, 628730, 689320, 689310, 771080, 874740, 990090, 058090, 058110, 097290, 132530, 225900, 274180, 274190, 325480, 325470, 339730, 411260, 425150, 579820, 579810, 625560, 625580, 659420, 659430, 659440, 731740, 789340, 789350, 858270, 904770, 270830, 270840, 270850, 270860, 270870, 281000, 281030, 281010, 281020, 281050, 281040, 392900, 392980, 458190, 458200, 535810, 535820, 535830, 617610, 617690, 617700, 615750, 702360, 863570, 863580, 863550, 863560, 993770, 993780, 993860, 089220, 089270, 089280, 232370, 492520, 492480, 492500, 569540, 569550, 739030, 492490, 845070, 900830, 738950, 900840, 739020, 981520, 046260, 046310, 046320, 981440, 981450, 126170, 212230, 126270, 212090, 212100, 212240, 314680, 314690, 361080, 412950, 412960, 470660, 487710, 361090, 550090, 731590, 753170, 753180, 753190, 753200, 866220, 913340, 913430, 913440, 047260, 131860, 131870, 177970, 177960, 226010, 225960, 226020, 316500, 316510, 372270, 428600, 543980, 543990, 544000, 544010, 544030, 679560, 679580, 679590, 788230, 788240, 971710, 045980, 045990, 166150, 166160, 364330, 317560, 317570, 317580, 317590, 525910, 525920, 525740, 525800, 525810, 697640, 697690, 697700, 836010, 835950, 923020, 923030, 922930, 922950, 047010, 047020, 047030, 444520, 444510, 444530, 444540, 444550, 444560, 500920, 500930, 500740, 500780, 500790, 555120, 806770, 839190, 839200, 839210, 839220, 839240, 839250, 027730, 081810, 955860, 955880, 081800, 136110, 347320, 347330, 347340, 347260, 347290, 347300, 486310, 486380, 588170, 588180, 588110, 588120, 729670, 004840, 004850, 004870, 004880, 004890, 004900, 004910, 004860, 432770, 432750, 432800, 432820, 432830, 432760, 432780, 432790, 735070, 554040, 554050, 554060, 554070, 554080, 554090, 554100, 554130, 554140, 554150, 554160, 554170, 557770, 557780, 557800, 557820, 557830, 557840, 557850, 557860, 557870, 557880, 557890, 598790, 839240R, 598810, 598820, 654490, 654500, 654510, 654520, 654530, 654540, 654550, 654560, 654580, 654590, 654600, 654610, 557810, 790010, 790060, 790070, 861790, 861800, 790030, 790040, 790050, 861810, 877440, 877450, 877460, 992570, 079050, 079060, 079070, 079090, 079100, 079130, 079140, 790020, 992580, 079120, 520680, 520690, 520700, 520720, 520730, 520740, 520750, 520760, 520770, 520790, 520810, 520830, 520850, 520870, 520710, 520780, 520800, 520820, 520840, 735000, 735040, 735050, 735030, 520670, 735010, 735020, 809150, 809160, 177600, 177630, 177650, 177670, 177690, 177710, 177620, 177700, 296540, 296650, 325700, 325680, 437610, 437620, 618630, 618660, 747030, 747040, 747050, 747070, 747270, 747280, 916360, 916370, 916390, 916400, 916380, 766580, 766570, 043740, 043750, 043770, 043800, 043820, 043810, 234940, 234860, 234870, 234880, 234890, 234950, 234960, 234970, 234980, 500780R, 461160, 461170, 461240, 294740, 294760, 294770, 294810, 294820, 294840, 294850, 294870, 294880, 294900, 319870, 319890, 319930, 319950, 319970, 320030, 294730, 294750, 294780, 294860, 294890, 294910, 319850, 319910, 319980, 699450, 699470, 709590, 709620, 709850, 710900, 713900, 713950, 713960, 844850, 709840, 712020, 712070, 712080, 712090, 804990, 805000, 818430, 818440, 818450, 818460, 830450, 830470, 830480, 830490, 830500, 830510, 830520, 844540, 844550, 844560, 845280, 845320, 851740, 851780, 851800, 851830, 879260, 879310, 879840, 879860, 894720, 894730, 894970, 895250, 895270, 895280, 035280, 035290, 879280, 879300, 894710, 894950, 894960, 894980, 895260, 915460, 915470, 995260, 995290, 995300, 995310, 995320, 996400, 996410, 996420, 035320, 035330, 035340, 122850, 123260, 153670, 153690, 153700, 996390, 996810, 171030, 245280, 035300, 171040, 171070, 171090, 200920, 200980, 201010, 201030, 201070, 201370, 231540, 231550, 231570, 231580, 231590, 231620, 231630, 231650, 245260, 245270, 245290, 245300, 245310, 245320, 245330, 245340, 245350, 245370, 864900, 461220, 064690, 064670, 834280, 064940, 064930, 107970, 142200, 142310, 089290, 186480, 197950, 237800, 285620. ***UDI Numbers*** (01)00880304001183(17)201228(10)410380, (01)00880304001183(17)221129(10)036380, (01)00880304001183(17)221205(10)095880, (01)00880304001183(17)221206(10)095890, (01)00880304001183(17)221206(10)095900, (01)00880304001183(17)221204(10)096130, (01)00880304001183(17)221206(10)096260, (01)00880304001183(17)221206(10)096310, (01)00880304001183(17)221205(10)096340, (01)00880304001183(17)221212(10)096280, (01)00880304001183(17)221217(10)242320, (01)00880304001183(17)221217(10)242340, (01)00880304001183(17)221214(10)242360, (01)00880304001183(17)230114(10)318790, (01)00880304001183(17)230118(10)527250, (01)00880304001183(17)230118(10)527260, (01)00880304001183(17)230117(10)527950, (01)00880304001183(17)230121(10)527240, (01)00880304001183(17)230118(10)527970, (01)00880304001183(17)230121(10)527990, 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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 27 of 33

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

Z-1664-2020
Recall number
Z-1664-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 28 of 33

BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

Z-1665-2020
Recall number
Z-1665-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 593990, 240410, 417130, 893160, 959150, 527310, 527330, 527320, 600520, 688340, 729310, 976980, 976990, 145250, 239320, 310120, 496420, 496430, 680300, 757940, 791580, 830280, 978080, 107640, 260580, 390560, 390570, 436970, 586690, 586700, 698800, 871250, 871260, 871270, 910920, 088360, 074100, 215500, 242860, 310440, 381750, 555620, 555630, 695540, 783280, 156170, 411620, 411630, 489600, 567470, 634040, 789380, 722610, 007780, 070930, 207270, 356340, 428250, 588730, 658370, 789420, 874750, 058080, 168510, 274140, 325430, 452250, 543120, 610640, 659380, 745490, 003770, 281100, 281110, 392870, 392960, 458240, 535750, 617660, 863650, 863630, 863640, 089300, 232450, 632660, 492530, 492540, 845110, 745860, 981500, 046280, 126240, 212190, 314660, 361130, 361140, 470650, 807180, 866170, 866260, 866300, 131830, 131850, 178030, 225990, 520650, 520660, 611540, 776850, 788270, 046020, 166190, 317630, 317640, 525840, 525940, 697720, 836030, 923060, 047060, 210250, 210110, 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285640.

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 29 of 33

BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

Z-1666-2020
Recall number
Z-1666-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 410520, 959170, 036440, 036450, 036460, 095920, 096370, 318810, 527340 527350, 527360, 528040, 600450, 600530, 688350, 729320, 793180, 857860, 977000, 074660, 074670, 145260, 145270, 145330, 239330, 239340, 239440, 496440, 496450, 496580, 680310, 680320, 749140, 729340, 757950, 821960, 821970, 821980, 926370, 025710, 099750, 165730, 247440, 247460, 247470, 352320, 436890, 436900, 459580, 490080, 490090, 562930, 586710, 632840, 632860, 632870, 708730, 708740, 772900, 969280, 996860, 996900, 010220, 051850, 413420, 413460, 242880, 413430, 413440, 413450, 461670, 518850, 583920, 583930, 667480, 667490, 822040, 056570, 156180, 220730, 270120, 270130, 411640, 411650, 434470, 525320, 525330, 540610, 540620, 634030, 688990, 722580, 738690, 823830, 823880, 823890, 970920, 970930, 070910, 070920, 108360, 207280, 257310, 339530, 413190, 548530, 548540, 588810, 643420, 643450, 672470, 706600, 706610, 907660, 976580, 225810, 225890, 274130, 281770, 281790, 369020, 512310, 512250, 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955920, 955900, 955830, 081820, 347380, 347370, 347310, 347270, 347280, 486410, 486420, 588210, 588130, 783180, 783120, 903270, 004970, 004980, 005000, 931820, 931870, 088140, 226000, 374530, 432930, 432910, 432920, 432940, 432900, 594300, 891880, 891890, 891910, 891870, 891900, 892140, 892150, 892170, 892210, 892220, 930550, 930560, 930570, 930580, 930590, 930600, 973120, 973130, 973150, 973160, 014720, 014730, 014740, 014750, 022430, 022440, 022460, 022470, 025050, 025130, 025140, 025150, 025160, 026770, 026780, 026930, 026940, 026950, 026960, 115760, 115820, 115860, 202740, 202750, 202760, 202770, 202780, 202790, 202800, 202820, 521440, 521450, 521460, 521470, 521500, 521520, 521560, 521680, 521740, 521750, 521760, 521770, 521780, 521830, 521840, 521850, 521870, 521880, 594310, 528040R, 809210, 177830, 177840, 296680, 325830, 437650, 437660, 618710, 747110, 747310, 747200, 916540, 914340, 916580, 916590, 916650, 916660, 378230, 378290, 378210, 378320, 378330, 378200, 766500, 766620, 766630, 766250, 044070, 044080, 044090, 044120, 044040, 044060, 460840, 025150R, 295620, 295640, 295650, 295670, 295690, 295710, 295720, 295730, 295750, 295760, 321510, 321530, 321570, 321580, 295600, 295630, 295680, 295700, 295740, 295610, 698770, 698790, 698820, 709680, 709710, 711050, 711070, 711090, 711220, 714040, 712230, 714030, 818560, 818570, 844640, 844650, 844660, 845500, 845520, 845540, 851930, 851980, 852000, 879380, 879390, 879410, 880070, 880100, 880110, 894790, 035910, 712190, 894780, 894810, 895300, 915500, 962960, 962990, 963020, 963800, 963810, 963820, 963950, 964750, 964760, 964770, 964900, 995970, 996520, 996540, 035890, 035920, 122890, 122960, 123150, 123160, 123170, 964910, 995830, 996020, 996050, 996490, 996500, 122880, 171110, 171290, 171300, 231790, 231820, 864910, 864920, 864930, 864950, 864960, 806420, 372290, 372350, 484770, 484780, 623170, 623180, 723370, 723380, 723400, 064750, 064740, 089370, 108030, 064970, 108020, 142330, 142350, 237900, 089350, 089360, 197980, 285650, 285680. ***UDI Numbers*** (01)00880304001824(17)210128(10)410520, (01)00880304001824(17)221128(10)959170, (01)00880304001824(17)221203(10)036440, (01)00880304001824(17)221201(10)036450, (01)00880304001824(17)221201(10)036460, (01)00880304001824(17)221211(10)095920, (01)00880304001824(17)221211(10)096370, (01)00880304001824(17)230111(10)318810, (01)00880304001824(17)230118(10)527340, (01)00880304001824(17)230117(10)527350, (01)00880304001824(17)230122(10)527360, (01)00880304001824(17)230118(10)528040, (01)00880304001824(17)230129(10)600450, (01)00880304001824(17)230129(10)600530, (01)00880304001824(17)230211(10)688350, (01)00880304001824(17)230211(10)729320, (01)00880304001824(17)230215(10)793180, (01)00880304001824(17)230228(10)857860, (01)00880304001824(17)230307(10)977000, (01)00880304001824(17)230326(10)074660, (01)00880304001824(17)230326(10)074670, (01)00880304001824(17)230422(10)145260, (01)00880304001824(17)230422(10)145270, 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(01)00880304001824(17)300122(10)089360, (01)00880304001824(17)300123(10)197980, (01)00880304001824(17)300122(10)285650, (01)00880304001824(17)300124(10)285680

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 30 of 33

BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

Z-1667-2020
Recall number
Z-1667-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 809860, 273440, 449670, 036470, 095940, 096460, 959200, 095930, 242330, 242370, 242380, 527370, 527380, 527390, 527400, 528050, 600460, 600540, 688360, 688410, 729340, 793190, 857870, 864610, 977010, 074680, 074690, 074700, 074800, 239360, 239370, 239450, 310130, 367720, 496460, 496470, 496590, 496600, 680330, 680340, 729350, 729360, 791590, 791600, 821990, 844550, 935790, 085550, 152260, 247480, 247490, 286760, 324080, 352330, 425640, 425650, 478220, 478230, 545200, 562940, 613890, 667650, 667670, 698810, 698820, 708750, 772910, 074110, 074120, 123170, 123180, 152790, 215690, 215730, 264980, 310460, 330920, 359680, 393080, 428840, 486280, 486290, 518860, 570270, 570280, 570290, 627900, 627910, 627920, 156190, 156200, 270140, 411660, 434480, 434490, 450660, 489560, 553380, 567590, 567610, 620050, 634080, 738670, 823850, 868850, 942680, 942690, 041310, 041340, 108340, 108350, 171410, 207290, 257320, 548550, 548560, 548570, 548580, 588800, 643460, 643470, 672490, 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697740, 697670, 836080, 835970, 922980, 922990, 923090, 047090, 047100, 047110, 210280, 210290, 210180, 210190, 351640, 351690, 351710, 500870, 675090, 674980, 674990, 675020, 675080, 771040, 806830, 955930, 081830, 081850, 193080, 193090, 193100, 347390, 486430, 486440, 486330, 486340, 588220, 588230, 783190, 783080, 783130, 783140, 005030, 931950, 931980, 931990, 005020, 088150, 088160, 374510, 374520, 594370, 594340, 594350, 594360, 594380, 594390, 735080, 301560, 629370, 629380, 629400, 629410, 629420, 891920, 629390, 891930, 891940, 892240, 930620, 930650, 930660, 930740, 930820, 973170, 973200, 014760, 014780, 014790, 022480, 022500, 022520, 022530, 025170, 025180, 025200, 025230, 026810, 026820, 026840, 026860, 026880, 026890, 026910, 026970, 026980, 026990, 027000, 027060, 930780, 973190, 973210, 014770, 025210, 202830, 202840, 202860, 202870, 202880, 202900, 202910, 202920, 522110, 522130, 522260, 522300, 522340, 522370, 522380, 522390, 522400, 522410, 522420, 522440, 522450, 594330, 633770, 674500, 674510, 633790, 633820, 809220, 809230, 177870, 177880, 177910, 177920, 177890, 296580, 325840, 437690, 437700, 177850, 618720, 747120, 747210, 747320, 747330, 916670, 916720, 916710, 378300, 378340, 378240, 378250, 378350, 766140, 766120, 766260, 766510, 766520, 766160, 766270, 766640, 044260, 044280, 044310, 044180, 461260, 461270, 461280, 461400, 295420, 295430, 295450, 295460, 295470, 295510, 295530, 295560, 295580, 322050, 295440, 295490, 295500, 295520, 295540, 295570, 295590, 322040, 698540, 698560, 698580, 698600, 709730, 710670, 710680, 710690, 711130, 711230, 714050, 714110, 714130, 845580, 852020, 712260, 712280, 818580, 818590, 830310, 830320, 830330, 830340, 830350, 830360, 844670, 844680, 844700, 844710, 845570, 845590, 845600, 845610, 845620, 852030, 852040, 852050, 852060, 852100, 852110, 879420, 879430, 879440, 879450, 879460, 879470, 879850, 879940, 879950, 034840, 034850, 034870, 963840, 964790, 964800, 964840, 964970, 034890, 034900, 034930, 122970, 122980, 123190, 123200, 123210, 153650, 153660, 963830, 964920, 996070, 996080, 996090, 034830, 308200, 308220, 308230, 308260, 352730, 657760, 657790, 657800, 657810, 694890, 028710, 806470, 806480, 073200, 095150, 095160, 095170, 095180, 372310, 372320, 484800, 623190, 723410, 064780, 064760, 064790, 089380, 064980, 108070, 142360, 108050, 237910, 089390, 108060, 108080, 285660, 285690. ***UDI Numbers*** (01)00880304002661(17)201028(10)809860, (01)00880304002661(17)211128(10)273440, (01)00880304002661(17)220628(10)449670, (01)00880304002661(17)221201(10)036470, (01)00880304002661(17)221203(10)095940, (01)00880304002661(17)221206(10)096460, (01)00880304002661(17)221201(10)959200, (01)00880304002661(17)221212(10)095930, (01)00880304002661(17)221217(10)242330, (01)00880304002661(17)221217(10)242370, (01)00880304002661(17)221217(10)242380, (01)00880304002661(17)230121(10)527370, (01)00880304002661(17)230122(10)527380, (01)00880304002661(17)230121(10)527390, 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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 31 of 33

BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

Z-1668-2020
Recall number
Z-1668-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 32 of 33

BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

Z-1669-2020
Recall number
Z-1669-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

***Lot Numbers*** 164050, 200280, 200310, 792540, 417400, 768490, 907050, 036500, 318820, 527430, 527420, 600560, 600570, 793200, 857880, 977030, 074710, 145290, 239380, 367730, 496490, 496500, 702500, 757960, 791610, 954460, 025760, 165750, 286790, 352340, 436910, 562950, 648450, 708780, 772920, 834070, 910840, 187220, 187730, 265000, 359710, 531380, 627930, 667500, 627940, 628010, 013140, 140060, 013180, 220750, 411690, 411700, 469140, 540630, 604560, 689000, 789400, 823840, 970940, 339470, 356320, 372740, 483860, 643480, 643490, 706580, 789470, 976620, 325370, 325380, 325390, 397400, 579910, 579920, 579930, 625680, 003830, 904720, 904730, 271000, 281240, 281250, 393050, 392880, 458290, 617770, 617650, 615790, 863770, 993840, 993920, 232440, 492620, 492630, 569680, 739000, 981590, 046390, 126340, 126200, 212300, 314740, 412930, 412940, 413010, 550280, 807330, 913510, 866250, 047310, 178020, 226110, 316470, 428550, 428580, 455020, 611610, 788330, 166250, 317740, 364300, 525890, 697770, 697620, 836100, 047150, 047160, 047170, 210210, 351740, 351650, 501030, 555130, 771020, 771060, 806850, 955990, 238970, 239020, 239070, 486450, 783200, 783150, 903280, 932080, 374610, 374580, 374590, 374600, 892000, 892390, 892020, 892040, 892430, 930920, 930930, 930940, 930950, 930990, 931020, 973290, 973300, 973320, 014840, 014850, 014860, 014870, 022580, 022600, 022610, 022620, 025290, 973310, 203010, 203020, 203050, 203060, 203070, 203080, 524270, 524250, 524280, 524310, 524320, 524340, 524350, 524370, 524380, 524400, 177950, 177960, 296610, 296690, 437710, 618730, 747130, 747220, 260080, 147730, 147770, 147780, 147810, 267240, 267250, 267300, 267330, 747130R, 267260, 267280, 267290, 267160, 460920, 460930, 460940, 460950, 460960, 322860, 322850, 322870, 699080, 699100, 710750, 710760, 711150, 711180, 712320, 714160, 714180, 818650, 818660, 844800, 844810, 852120, 879400, 894870, 894880, 122410, 122440, 123230, 879510, 894860, 915600, 963470, 963920, 964890, 035940, 104990, 105010, 122430, 123000, 123060, 963960, 996230, 996240, 399760, 399780, 399790, 399840, 417120, 417150, 399740, 399750, 399770, 399800, 399870, 417130, 417160, 417250, 123220, 864970, 864980, 864990, 142290, 142370, 089410, 285710, ***UDI Numbers*** (01)00880304007031(17)201128(10)164050, (01)00880304007031(17)210328(10)200280, (01)00880304007031(17)210328(10)200310, (01)00880304007031(17)210528(10)792540, (01)00880304007031(17)220328(10)417400, (01)00880304007031(17)220528(10)768490, (01)00880304007031(17)220528(10)907050, (01)00880304007031(17)221201(10)036500, (01)00880304007031(17)230111(10)318820, (01)00880304007031(17)230117(10)527430, (01)00880304007031(17)230121(10)527420, (01)00880304007031(17)230129(10)600560, (01)00880304007031(17)230129(10)600570, (01)00880304007031(17)230215(10)793200, (01)00880304007031(17)230228(10)857880, (01)00880304007031(17)230307(10)977030, (01)00880304007031(17)230326(10)074710, (01)00880304007031(17)230422(10)145290, 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(01)00880304007031(17)250311(10)492630, (01)00880304007031(17)250331(10)569680, (01)00880304007031(17)250428(10)739000, (01)00880304007031(17)250428(10)981590, (01)00880304007031(17)250505(10)046390, (01)00880304007031(17)250516(10)126340, (01)00880304007031(17)250529(10)126200, (01)00880304007031(17)250529(10)212300, (01)00880304007031(17)250611(10)314740, (01)00880304007031(17)250618(10)412930, (01)00880304007031(17)250618(10)412940, (01)00880304007031(17)250619(10)413010, (01)00880304007031(17)250625(10)550280, (01)00880304007031(17)250720(10)807330, (01)00880304007031(17)250728(10)913510, (01)00880304007031(17)250731(10)866250, (01)00880304007031(17)250812(10)047310, (01)00880304007031(17)250825(10)178020, (01)00880304007031(17)250901(10)226110, (01)00880304007031(17)250915(10)316470, (01)00880304007031(17)250923(10)428550, (01)00880304007031(17)250924(10)428580, (01)00880304007031(17)250924(10)455020, (01)00880304007031(17)251005(10)611610, (01)00880304007031(17)251027(10)788330, (01)00880304007031(17)251124(10)166250, (01)00880304007031(17)251208(10)317740, (01)00880304007031(17)251214(10)364300, (01)00880304007031(17)260105(10)525890, (01)00880304007031(17)260112(10)697770, (01)00880304007031(17)260121(10)697620, (01)00880304007031(17)260120(10)836100, (01)00880304007031(17)260212(10)047150, (01)00880304007031(17)260212(10)047160, (01)00880304007031(17)260224(10)047170, (01)00880304007031(17)260301(10)210210, (01)00880304007031(17)260308(10)351740, (01)00880304007031(17)260315(10)351650, (01)00880304007031(17)260317(10)501030, (01)00880304007031(17)260329(10)555130, (01)00880304007031(17)260412(10)771020, (01)00880304007031(17)260413(10)771060, (01)00880304007031(17)260414(10)806850, (01)00880304007031(17)260428(10)955990, (01)00880304007031(17)260524(10)238970, (01)00880304007031(17)260523(10)239020, (01)00880304007031(17)260524(10)239070, (01)00880304007031(17)260611(10)486450, (01)00880304007031(17)260708(10)783200, (01)00880304007031(17)260715(10)783150, (01)00880304007031(17)260718(10)903280, (01)00880304007031(17)260720(10)932080, (01)00880304007031(17)260824(10)374610, (01)00880304007031(17)260826(10)374580, (01)00880304007031(17)260827(10)374590, (01)00880304007031(17)260826(10)374600, (01)00880304007031(17)270609(10)892000, (01)00880304007031(17)270609(10)892390, (01)00880304007031(17)270616(10)892020, (01)00880304007031(17)270615(10)892040, (01)00880304007031(17)270615(10)892430, (01)00880304007031(17)270616(10)930920, (01)00880304007031(17)270616(10)930930, (01)00880304007031(17)270615(10)930940, (01)00880304007031(17)270616(10)930950, (01)00880304007031(17)270616(10)930990, (01)00880304007031(17)270616(10)931020, (01)00880304007031(17)270617(10)973290, (01)00880304007031(17)270616(10)973300, (01)00880304007031(17)270617(10)973320, (01)00880304007031(17)270624(10)014840, (01)00880304007031(17)270623(10)014850, (01)00880304007031(17)270625(10)014860, (01)00880304007031(17)270623(10)014870, (01)00880304007031(17)270622(10)022580, 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(01)00880304007031(17)271220(10)437710, (01)00880304007031(17)280104(10)618730, (01)00880304007031(17)280120(10)747130, (01)00880304007031(17)280119(10)747220, (01)00880304007031(17)280221(10)260080, (01)00880304007031(17)280419(10)147730, (01)00880304007031(17)280423(10)147770, (01)00880304007031(17)280419(10)147780, (01)00880304007031(17)280419(10)147800, (01)00880304007031(17)280424(10)147810, (01)00880304007031(17)280425(10)267240, (01)00880304007031(17)280425(10)267250, (01)00880304007031(17)280425(10)267300, (01)00880304007031(17)280425(10)267330, (01)00880304007031(17)280120(10)747130R, (01)00880304007031(17)280503(10)267260, (01)00880304007031(17)280427(10)267280, (01)00880304007031(17)280427(10)267290, (01)00880304007031(17)280509(10)267160, (01)00880304007031(17)280509(10)460920, (01)00880304007031(17)280509(10)460930, (01)00880304007031(17)280509(10)460940, (01)00880304007031(17)280509(10)460950, (01)00880304007031(17)280510(10)460960, (01)00880304007031(17)290203(10)322860, 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Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

device · product 33 of 33

BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.

Z-1670-2020
Recall number
Z-1670-2020
Initiated
February 26, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Code information

Lot Number 800940

Distribution pattern

Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.