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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83962

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

Open FDA event record

Event summary

Timeline bucket
October 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer 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

41 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 41

BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100

Z-0298-2020
Recall number
Z-0298-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 2 of 41

Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100

Z-0299-2020
Recall number
Z-0299-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 3 of 41

Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525

Z-0300-2020
Recall number
Z-0300-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 4 of 41

Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510822 32855510843 32855510844

Z-0301-2020
Recall number
Z-0301-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 5 of 41

Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510808 32855510822 32855510843 32855510844 32855140373 32855411710 32855430479 32855430480 32855430496 32855430498 32855430519 32855430529 32855430533 32855430535 32855430542 32855430544 32855430582 32855430588 32855450430 32855450439 32855450471 32855450483 32855450525 32855470651 32855470715 32855470793 32855470795 32855470796 32855470866 32855470920 32855470921 32855470923 32855480803 32855480808 32855480823 32855480824 32855480828 32855480829 32855480945 32855480963 32855480990 32855481016 32855910440 32855910454 32855910455 32855910456 32855910475 32855910485 32873400307

Z-0302-2020
Recall number
Z-0302-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 6 of 41

NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313

Z-0303-2020
Recall number
Z-0303-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 7 of 41

NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014

Z-0304-2020
Recall number
Z-0304-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 8 of 41

ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47235701714 47235701716 47235701804 47235701806 47235701808 47235701810 47235701812 47235701814 47235701816

Z-0305-2020
Recall number
Z-0305-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 9 of 41

TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600

Z-0306-2020
Recall number
Z-0306-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 10 of 41

Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 00234700412 00234700414 00234700416 00234700502 00234700504 00234700506 00234700508 00234700510 00234700512 00234700514 00234700602 00234700604 00234700606 00234700608 00234700610 00234700612 00234700614 00234700704 00234700706 00234700708 00234700710 00234700712 00234700714 00234700716 00234700718 00234700720 00234700804 00234700806 00234700808 00234700810 00234700812 00234700814 00234700816 00234700818 00234700820 00234700904 00234700906 00234700908 00234700910 00234700912 00234700914 00234700916 00234700918 00234700920 00234701004 00234701006 00234701008 00234701010 00234701012 00234701014 00234701016 00234701018 00234701020 00234701104 00234701106 00234701108 00234701110 00234701204 00234701206 00234701208 00234701210 00234701304 00234701306 00234701308 00234701404 00234701406 00234701408 00234703500 00234703600

Z-0307-2020
Recall number
Z-0307-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 11 of 41

PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204 00234703206 00234703208

Z-0308-2020
Recall number
Z-0308-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 12 of 41

Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 47235700518 47235700604 47235700606 47235700608 47235700610 47235700612 47235700614 47235700618 47235700706 47235700708 47235700710 47235700714 47235700808 47235700810 47235700814 47235700906 47235700908 47235700914 47235700918 47235701006 47235701008 47235701010

Z-0309-2020
Recall number
Z-0309-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 13 of 41

DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222

Z-0310-2020
Recall number
Z-0310-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 14 of 41

SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210

Z-0311-2020
Recall number
Z-0311-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 15 of 41

Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007 47492801013 47492801207 47492801213 47492801413 47492801607 47492801613 47492801702 47492801802 47492801813 47492801902 47492802002 47492802013 47493600313 47493600403 47493600407 47493600413 47493600503 47493600507 47493600513 47493600603 47493600607 47493600613 47493600703 47493600707 47493600713 47493600803 47493600807 47493600813 47493600907 47493600913 47493601003 47493601007 47493601013 47493601113 47493601203 47493601207 47493601213 47493601313 47493601403 47493601407 47493601413 47493601513 47493601607 47493601613 47493601813 47493602007 47493602013 47493602213 47493603305 47493603306 47493603405 47493603406 47493603504 47493604604 47493800303 47493800402 47493800502 47493800603 47493800613 47493800702 47493800703 47493800802 47493800803 47493800902 47494600403 47494600407 47494600413 47494600503 47494600507 47494600513 47494600603 47494600607 47494600613 47494600703 47494600707 47494600713 47494600803 47494600807 47494600813 47494600913 47494601003 47494601013 47494601113 47494601203 47494601213 47494603305 47494603306 47494603405 47494603406 47494603504 47494604604

Z-0312-2020
Recall number
Z-0312-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 16 of 41

PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

Z-0313-2020
Recall number
Z-0313-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 17 of 41

Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 00234800612 00234800614 00234800712 00234800714 00234800716 00234800902 00234800904 00234800906 00234800908 00234800910 00234800912 00234800914 00234801002 00234801004 00234801006 00234801008 00234801010 00234801012

Z-0314-2020
Recall number
Z-0314-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 18 of 41

PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 00234802112 00234802204 00234802206 00234802208 00234802212 00234802508 00234802510 00234802608

Z-0315-2020
Recall number
Z-0315-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 19 of 41

PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212

Z-0316-2020
Recall number
Z-0316-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 20 of 41

Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235800807 47235800811 47235800815 47235800911 47235800913 47235800915 47235801209 47235801211 47235801213 47235801215 47235802305 47235802307 47235802311 47235802315 47235802405 47235802407 47235802409 47235802411 47235802415 47235810707 47235810711 47235810715 47235810805 47235810807 47235810811 47235810815

Z-0317-2020
Recall number
Z-0317-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 21 of 41

Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248 00151506448 00151506648 00400500060 00401000038 00401000040 00401000041 00401000042 00401000043 00401000044 00401000045 00401000046 00401000047 00401000048 00401000049 00401000050 00401000051 00401000052 00401000053 00401000054 00401000055 00402100857 00402100863 00402101243 00402101244 00402200040 00402200042 00402200051 00402200057 00408801106 00408801206 00408801226 00408801236 00408801306 00408801326 00408801336 00408801356 00408801376 00408801406 00408801426 00408801436 00408801456 00408801476 00408801506 00408801526 00408801536 00408801556 00408801576 00408801606 00408801626 00408801636 00408801656 00408801706 00408801806 00455500700 00455501001 00455502000 00455502001 00455503000 00455503001 00455504001 00500103800 00500103900 00500104000 00500104100 00500104200 00500104300 00500104400 00500104500 00500104600 00500104700 00500104800 00500104900 00500105000 00500105100 00500105200 00500105300 00500105400 00500105500 00500105700 00500105800 00500106000 00500106200 00500106400 00500106600 00500106800 00500107000 00620003620 00620003820 00620004020 00620004021 00620004023 00620004220 00620004221 00620004223 00620004420 00620004421 00620004423 00620004424 00620004620 00620004621 00620004623 00620004820 00620004821 00620004822 00620004823 00620005020 00620005021 00620005022 00620005023 00620005220 00620005221 00620005222 00620005223 00620005420 00620005421 00620005422 00620005423 00620005424 00620005620 00620005621 00620005622 00620005623 00620005624 00620005820 00620005821 00620005822 00620005823 00620005824 00620006020 00620006021 00620006022 00620006023 00620006220 00620006221 00620006222 00620006223 00620006224 00620006420 00620006421 00620006422 00620006423 00620006620 00620006621 00620006622 00620006623 00620006624 00620006820 00620006821 00620006822 00620006823 00620006824 00620007020 00620007021 00620007022 00620007023 00620007220 00620007620 00620008020 00620104800 00620105000 00620105200 00620105400 00620105600 00620105800 00620106000 00620106200 00620106400 00620106600 00620107000 00620203820 00620203822 00620204020 00620204022 00620204220 00620204222 00620204420 00620204422 00620204620 00620204622 00620204820 00620204821 00620204822 00620205020 00620205021 00620205022 00620205220 00620205221 00620205222 00620205420 00620205421 00620205422 00620205620 00620205621 00620205622 00620205820 00620205821 00620205822 00620206020 00620206022 00620206220 00620206222 00620206420 00620206422 00620206620 00620206622 00620206820 00620206822 00620207020 00620207022 00620207220 00620207420 00620207620 00620208020 00633410132 00640004822 00640005020 00640005022 00640005222 00640005420 00640005422 00640005620 00640005622 00640005822 00640006022 00640006220 00640006222 00640006420 00640006422 00640006620 00640006622 00640006820 00640006822 00640007020 00640007022 00671000301 00671000302 00671000401 00671000402 00671000501 00671000502 00671000601 00671000602 00671000701 00671000702 00671000801 00671000802 00671000901 00671000902 00672000102 00672000111 00672000112 00672000201 00672000202 00672000211 00672000212 00672000311 00672000411 00672000412 00672000501 00672000502 00672000512 00672000601 00672000602 00672000611 00672000612 00763301100 00763301200 00763301300 00763301400 00763401000 00763401100 00763401200 00763401300 00763401400 00763401500 00763401600 00765301101 00765301140 00765301201 00765301240 00765301301 00765301340 00765301401 00765301440 00765301501 00765301540 00765301601 00765401100 00765401400 00771100410 00771100440 00771100500 00771100510

Z-0318-2020
Recall number
Z-0318-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 22 of 41

CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200

Z-0319-2020
Recall number
Z-0319-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 23 of 41

Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103 0100551104 0100551105 0100551106 0100551107 0100551108 0100551109 0100551110 0100551111 0100551112 0100551113 0100551114 0100551201 0100551202 0100551203 0100551204 0100551205 0100551206 0100551207 0100551208 0100551209 0100551210 0100551211 0100551212 0100551213 0100551214 0100551301 0100551302 0100551303 0100551304 0100551305 0100551306 0100551307 0100551308 0100551309 0100551310 0100551311 0100551312 0100551313 0100551314 0100551401 0100551402 0100551403 0100551404 0100551405 0100551406 0100551407 0100551408 0100551409 0100551410 0100551411 0100551412 0100551413 0100551414

Z-0320-2020
Recall number
Z-0320-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 24 of 41

Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401 00541001501 00541001502 00541001601 00541001602 00541001701 00541001702 00541001801 00541001802 00541201501 00541201502 00541201601 00541201602 00541201701 00541201702 00541201801 00541201802 00541401301 00541401302 00541401401 00541401402 00541401501 00541401502 00541401601 00541401602 00541401701 00541401702 00541601401 00541601402 00541601501 00541601502 00541601601 00541601602 00575001301 00575001302 00575001305 00575001306 00575001401 00575001402 00575001405 00575001406 00575001501 00575001502 00575001505 00575001506 00575001601 00575001602 00575001605 00575001606 00575001701 00575001702 00575001705 00575001706 00575201301 00575201302 00575201305 00575201306 00575201401 00575201402 00575201405 00575201406 00575201501 00575201502 00575201505 00575201506 00575201601 00575201602 00575201605 00575201606 00575201701 00575201702 00575201705 00575201706 00576201351 00576201352 00576201451 00576201452 00576201551 00576201552 00576201651 00576201652 00576201751 00576201752 00576401351 00576401352 00576401451 00576401452 00576401551 00576401552 00576401651 00576401652 00576401751 00576401752 00579002000 00579002100 00579002200 00579002300 00579002400 00579002500 00579002600 00579002700 00579002800 00579002900 00579004511 00579004512 00579005511 00579005512 00579006511 00579006512 00579007511 00579007512 00584200101 00584200102 00584200201 00584200202 00584200301 00584200302 00584200401 00584200402 00584200501 00584200502 00584200601 00584200602 00584201101 00584201102 00584201201 00584201202 00584201301 00584201302 00584201401 00584201402 00584201501 00584201502 00584201601 00584201602 00584201701 00584201702 00588000110 00588000210 00588000310 00588000410 00588000510 00588000610 00591602000 00591602001 00591603000 00591603001 00591604000 00591604001 00591604017 00591605000 00591605001 00591605017 00591606000 00591606001 00591607000 00591607001 00591607020 00591608000 00591608001 00591800200 00591800300 00591800400 00591800500 00591800600 00591800700 00591800800 00592601101 00592601102 00592601201 00592601202 00592601301 00592601302 00592601401 00592601402 00592601501 00592601502 00595001201 00595001202 00595001301 00595001302 00595001305 00595001306 00595001401 00595001402 00595001405 00595001406 00595001501 00595001502 00595001505 00595001506 00595001601 00595001602 00595001605 00595001606 00595001701 00595001702 00595001705 00595001706 00595002701 00595002702 00595003701 00595003702 00595003712 00595004701 00595004702 00595005701 00595005702 00595006745 00595006775 00595009000 00595201201 00595201202 00595201301 00595201302 00595201305 00595201306 00595201401 00595201402 00595201405 00595201406 00595201501 00595201502 00595201505 00595201506 00595201601 00595201602 00595201605 00595201606 00595201701 00595201702 00595201705 00595201706 00595409000 00595601201 00595601202 00595601301 00595601302 00595601305 00595601306 00595601401 00595601402 00595601405 00595601406 00595601501 00595601502 00595601505 00595601506 00595601601 00595601602 00595601605 00595601606 00595601701 00595601702 00595601705 00595601706 00596001151 00596001152 00596001251 00596001252 00596001351 00596001352 00596001451 00596001452 00596001551 00596001552 00596001651 00596001652 00596001751 00596001752 00596001851 00596001852 00596003701 00596003702 00596003710 00596004701 00596004702 00596004710 00596005701 00596005710 00596009900 00596201251 0059620125

Z-0321-2020
Recall number
Z-0321-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 25 of 41

Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148

Z-0322-2020
Recall number
Z-0322-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 26 of 41

Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011

Z-0323-2020
Recall number
Z-0323-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All product manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 27 of 41

LPS-MOB ART SURF IMPL D 9MM

Z-0324-2020
Recall number
Z-0324-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

62067796

Distribution pattern

Distributed nationwide.

device · product 28 of 41

Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 32855430536 32855430537 32855430538 32855430539 32855430541 32855430543 32855430546 32855430548 32855430549 32855430550 32855430551 32855430556 32855430557 32855430558 32855430563 32855430565 32855430567 32855430568 32855430569 32855430570 32855430574 32855430575 32855430577 32855450420 32855450441 32855450453 32855450461 32855450499 32855470626 32855470639 32855470641 32855470644 32855470645 32855470648 32855470649 32855470652 32855470653 32855470654 32855470660 32855470663 32855470666 32855470667 32855470669 32855470672 32855470673 32855470679 32855470680 32855470682 32855470683 32855470684 32855470686 32855470688 32855470689 32855470692 32855470693 32855470694 32855470695 32855470698 32855470699 32855470700 32855470701 32855470704 32855470705 32855470706 32855470707 32855470709 32855470710 32855470712 32855470717 32855470719 32855470721 32855470722 32855470725 32855470726 32855470727 32855470728 32855470729 32855470730 32855470732 32855470733 32855470739 32855470741 32855470742 32855470743 32855470744 32855470745 32855470746 32855470749 32855470750 32855470752 32855470753 32855470761 32855470764 32855470765 32855470766 32855470767 32855470768 32855470769 32855470770 32855470771 32855470772 32855470773 32855470774 32855470775 32855470777 32855470778 32855470779 32855470782 32855470783 32855470785 32855470790 32855470791 32855470801 32855470804 32855470805 32855470806 32855470807 32855470808 32855470809 32855470810 32855470811 32855470813 32855470814 32855470815 32855470816 32855470817 32855470818 32855470825 32855470826 32855470831 32855470843 32855470844 32855470851 32855470856 32855470857 32855470858 32855470859 32855470860 32855470861 32855470862 32855470864 32855470867 32855470875 32855470884 32855470885 32855470900 32855470901 32855470902 32855470905 32855470906 32855470907 32855470908 32855470909 32855470910 32855470911 32855470924 32855470929 32855480907 32855480914 32855480918 32855480928 32855480938 32855480955 32855480993 32855480994 32855480996 32855480997

Z-0325-2020
Recall number
Z-0325-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 29 of 41

Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 00118100542 00118100550 00118100552 00118100562 00118100565 00118100567 00118101022 00118101025 00118101027 00118101030 00118101032 00118101035 00118101037 00118101040 00118101042 00118101045 00118101047 00118101050 00118101052 00118101055 00118101057 00118101060 00118101522 00118101525 00118101527 00118101530 00118101532 00118101547 00118101552 00118101557 00118109006 00118109008 00118109010 00118109506 00118109510 00118113002 00118113003 00118113004 00118113005 00118113006 00118113008 00118113010 00118113012 00118113094 00118113502 00118113503 00118113504 00118113505 00118113506 00118113508 00118113510 00118113512 00118113514 00118113594 00118113595 00118114002 00118114003 00118114004 00118114005 00118114006 00118114008 00118114010 00118114012 00118114014 00118114094 00118114095 00118114502 00118114503 00118114504 00118114505 00118114506 00118114508 00118114510 00118114512 00118114514 00118114594 00118114595 00118115002 00118115003 00118115004 00118115005 00118115006 00118115008 00118115010 00118115012 00118115094 00119300520 00119300522 00119300525 00119300537 00119301020 00119301022 00119301025 00119301027 00119301030 00119301032 00119301035 00119301037 00119301040 00119301042 00119301045 00119301047 00119301050 00119301052 00119301057 00119301070 00119301520 00119301522 00119301525 00119301530 00119301532 00119301535 00119301537 00119301540 00119301542 00119301545 00119301547 00119301550 00119301552 00119301555 00119301557 00119301560 00119301562 00119301567 00119309008 00119309010 00119309012 00119309014 00119309506 00119309508 00119309510 00119309512 00119309514 00119309516 00119309522 00119313002 00119313003 00119313004 00119313005 00119313006 00119313008 00119313010 00119313012 00119313016 00119313094 00119313095 00119313096 00119313502 00119313503 00119313504 00119313505 00119313506 00119313508 00119313510 00119313512 00119313514 00119313516 00119313594 00119313595 00119313596 00119314002 00119314003 00119314004 00119314005 00119314006 00119314008 00119314010 00119314012 00119314018 00119314094 00119314095 00119314096 00119314502 00119314503 00119314504 00119314505 00119314506 00119314508 00119314510 00119314512 00119314514 00119314516 00119314520 00119314594 00119314595 00119314596 00119315003 00119315004 00119315005 00119315006 00119315008 00119315010 00119315012 00119315014 00119315016 00119315018 00119315020 00119315094 00119315095 00119315096 00119413004 00119413005 00119413006 00119413008 00119413504 00119413505 00119413506 00119413508 00119413594 00119413595 00119413596 00119414004 00119414005 00119414006 00119414008 00119414504 00119414505 00119414506 00119414508 00119415004 00119415005 00119415006 00119415008 00223200118 00223200128 00223200228 00223200301 00223200302 00223200303 00223200318 00223200418 00223200518 00223201113 00223202113 00223205018 00223205019 00223205020 00223205021 47223206000 47223206035 47223206055 47249134015 47249136015 47249140015 47249142015 47249144015 47249146015 47249148009 47249148010 47249148011 47249148012 47249148013 47249148014 47249148015 47249248009 47249248010 47249248011 47249248012 47249248013 47249248014 47249248109 47249248110 47249248111 47249248112 47249248113 47249248114 47349134009 47349134010 47349134011 47349134012 47349134013 47349134014 47349134015 47349136009 47349136010 47349136011 47349136012 47349136013 47349136014 47349136015 47349138009 47349138010 47349138011 47349138012 47349138013 47349138014 47349138015 47349140009 47349140010 47349140011 47349140012 47349140013 47349140014 47349140015 47349142009 47349142010 473491420

Z-0326-2020
Recall number
Z-0326-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 30 of 41

CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202

Z-0327-2020
Recall number
Z-0327-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

77001932 77001933 77001878 62176030 62112090 62146839

Distribution pattern

Distributed nationwide.

device · product 31 of 41

Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024 00224001026 00224001028 00224001030 00224001032 00224001034 00224001036 00224001038 00224001040 00224001042 00224001046 00224001048 00224001114 00224001116 00224001118 00224001120 00224001122 00224001124 00224001126 00224001128 00224001130 00224001132 00224001134 00224001136 00224001138 00224001140 00224001142 00224001144 00224001146 00224001214 00224001216 00224001218 00224001220 00224001222 00224001224 00224001226 00224001228 00224001230 00224001232 00224001234 00224001236 00224001238 00224001240 00224001242 00224001244 00224001246 00224001248 00224001314 00224001316 00224001318 00224001320 00224001322 00224001324 00224001326 00224001328 00224001330 00224001332 00224001334 00224001336 00224001338 00224001340 00224001342 00224001344 00224001346 00224001348 00224001414 00224001416 00224001418 00224001424 00224001426 00224001428 00224001430 00224001432 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 00225224008 00225224009 00225224010 00225224012 00225224013 00225226008 00225226009 00225226010 00225226011 00225226012 00225226013 00225228008 00225228009 00225228010 00225228011 00225228012 00225228013 00225228014 00225230008 00225230009 00225230010 00225230011 00225230012 00225230013 00225230014 00225230015 00225230016 00225232008 00225232009 00225232010 00225232011 00225232012 00225232013 00225232014 00225232015 00225232016 00225234008 00225234009 00225234010 00225234011 00225234012 00225234013 00225234014 00225234015 00225234016 00225236008 00225236009 00225236010 00225236011 00225236012 00225236013 00225236014 00225236015 00225236016 00225238008 00225238009 00225238010 00225238011 00225238012 00225238013 00225238014 00225240008 00225240009 00225240010 00225240011 00225240012 00225240013 00225240014 00225240015 00225242008 00225242009 00225242010 00225242011 00225242012 00225242013 00225242014 00225242015 00225242016 00225244008 00225244009 00225244010 00225244011 00225244012 00225244013 00225244014 00225244015 00225244016 00225246009 00225246010 00225246011 00225246012 00225246013 00225246014 00225246016 00225248010 00225248011 00225248012 00225248013 00225248014 00225248015 00225248016 00225250013 00225250014 00225250015 00225250016 00225318006 00225318008 00225318009 00225318011 00225320008 00225320009 00225320010 00225320011 00225320012 00225322006 00225322007 00225322008 00225322009 00225322010 00225322011 00225322012 00225322013 00225324006 00225324007 00225324008 00225324009 00225324010 00225324011 00225324012 00225324013 00225324014 00225326006 00225326007 00225326008 00225326009 00225326010 00225326011 00225326012 00225326013 00225326014 00225326015 00225328007 00225328008 00225328009 00225328010 00225328011 00225328012 00225328013 00225328014 00225328015 00225330006 00225330007 00225330008 00225330009 00225330010 00225330011 00225330012 00225330014 00225330015 00225332006 00225332007 00225332008 00225332009 00225332010 00225332011 00225332012 00225332013 00225332014 00225332015 00225334006 00225334007 00225334008 00225334009 00225334010 00225334011 00225334012 00225334013 00225334014 00225334015 00225336006 00225336007 00225336008 00225336009 00225336010 00225336011 00225336012 00225336013 00225336014 00225336015 00225338006 00225338007 00225338008 00225338009 00225338010 00225338011 00225338012 00225338013 00225338014 00225338015 00225340007 00225340008 002253400

Z-0328-2020
Recall number
Z-0328-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 32 of 41

Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700

Z-0329-2020
Recall number
Z-0329-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 33 of 41

Connection Screw for NCB Plate, Item No. 0202266002

Z-0330-2020
Recall number
Z-0330-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

12775518 12775518 12775527 12775527 12806273 12746627 12746627 12797742

Distribution pattern

Distributed nationwide.

device · product 34 of 41

NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018

Z-0331-2020
Recall number
Z-0331-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 35 of 41

NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107

Z-0332-2020
Recall number
Z-0332-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 36 of 41

FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165

Z-0333-2020
Recall number
Z-0333-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 37 of 41

Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240 00877002340

Z-0334-2020
Recall number
Z-0334-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 38 of 41

Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005

Z-0335-2020
Recall number
Z-0335-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 39 of 41

Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004

Z-0336-2020
Recall number
Z-0336-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 40 of 41

Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310 47249318311 47249318313 47249318314 47249321010 47249321011 47249321013 47249321014 47249321110 47249321111 47249321113 47249321114 47249321210 47249321211 47249321213 47249321214 47249321310 47249321311 47249321313 47249321314 47249321410 47249321411 47249321413 47249321414 47249321510 47249321511 47249321513 47249321514 47249330010 47249330011 47249330013 47249330110 47249330111 47249330113 47249330210 47249330211 47249330213 47249330310 47249330311 47249330313 47249330410 47249330411 47249330413 47249330510 47249330511 47249330513 47249332010 47249332011 47249332013 47249332110 47249332111 47249332113 47249332210 47249332211 47249332213 47249332310 47249332311 47249332313 47249332410 47249332411 47249332413 47249332510 47249332511 47249332513 47249334010 47249334011 47249334013 47249334110 47249334111 47249334113 47249334210 47249334211 47249334213 47249334310 47249334311 47249334313 47249334410 47249334411 47249334413 47249334510 47249334511 47249334513 47249336010 47249336011 47249336013 47249336110 47249336111 47249336113 47249336210 47249336211 47249336213 47249336310 47249336311 47249336313 47249336410 47249336411 47249336413 47249336510 47249336511 47249336513 47249338010 47249338011 47249338013 47249338110 47249338111 47249338113 47249338210 47249338211 47249338213 47249338310 47249338311 47249338313 47249338410 47249338411 47249338413 47249338510 47249338511 47249338513 47249340010 47249340011 47249340013 47249340110 47249340111 47249340113 47249340210 47249340211 47249340213 47249340310 47249340311 47249340313 47249340410 47249340411 47249340413 47249340510 47249340511 47249340513 47249342010 47249342011 47249342013 47249342110 47249342111 47249342113 47249342210 47249342211 47249342213 47249342310 47249342311 47249342313 47249342410 47249342411 47249342413 47249342510 47249342511 47249342513 47249344010 47249344011 47249344013 47249344110 47249344111 47249344113 47249344210 47249344211 47249344213 47249344310 47249344311 47249344313 47249344410 47249344411 47249344413 47249344510 47249344511 47249344513 47249346010 47249346011 47249346013 47249346110 47249346111 47249346113 47249346210 47249346211 47249346213 47249346310 47249346311 47249346313 47249346410 47249346411 47249346413 47249346510 47249346511 47249346513 47249348010 47249348011 47249348013 47249348110 47249348111 47249348113 47249348210 47249348211 47249348213 47249348310 47249348311 47249348313 47249348410 47249348411 47249348413 47249348510 47249348511 47249348513

Z-0337-2020
Recall number
Z-0337-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

All products manufactured prior to January 2014.

Distribution pattern

Distributed nationwide.

device · product 41 of 41

cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

Z-0338-2020
Recall number
Z-0338-2020
Initiated
October 10, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
5459583 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information

12752657 12784266 12784266 12784266 12778187 12778187 12752661 12784267 12784267 12784267 12776194 12784268 12784268 12784268 12774326 12753709 12753702 12753707 12784261

Distribution pattern

Distributed nationwide.