Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93687

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

Open FDA event record

Event summary

Timeline bucket
December 01, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Howmedica Osteonics Corp.

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

58 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 58

SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026

Z-0869-2024
Recall number
Z-0869-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
94 units US; 131 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033779 Lot Numbers: PVDY TEN1 AMN1 V644 MHHE 4T1K V355 55LK JR6R

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 2 of 58

SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028

Z-0870-2024
Recall number
Z-0870-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
52 units US; 20 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033793 Lot Numbers: A59N, EP7J , X79L

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 3 of 58

SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030

Z-0871-2024
Recall number
Z-0871-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
77 units US; 2 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033809 Lot Numbers: PD99, 6AHH, RY3J

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 4 of 58

SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032

Z-0872-2024
Recall number
Z-0872-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
70 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033823 Lot Numbers: 6LR4, R14V, N882

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 5 of 58

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515

Z-0873-2024
Recall number
Z-0873-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034042 Lot Numbers: WK4PX0

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 6 of 58

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524

Z-0874-2024
Recall number
Z-0874-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034073 Lot Numbers: K349TP

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 7 of 58

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

Z-0875-2024
Recall number
Z-0875-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034349 Lot Numbers: TA21X9

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 8 of 58

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510

Z-0876-2024
Recall number
Z-0876-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034363 Lot Numbers: H43RDK, WR1RE3, 768NEY, 4J13P1

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 9 of 58

SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512

Z-0877-2024
Recall number
Z-0877-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034790 Lot Numbers: 5M6LM1

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 10 of 58

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

Z-0878-2024
Recall number
Z-0878-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034820 Lot Numbers: 482LM8, HH43K7

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 11 of 58

SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516

Z-0879-2024
Recall number
Z-0879-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034806 Lot Numbers: TN1746, KK82WY

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 12 of 58

SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518

Z-0880-2024
Recall number
Z-0880-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
5 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034813 Lot Numbers: 9P8360, AK8393

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 13 of 58

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521

Z-0881-2024
Recall number
Z-0881-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034837 Lot Numbers: VA0X4T

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 14 of 58

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524

Z-0882-2024
Recall number
Z-0882-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327034844 Lot Numbers: V68WW1,93400601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 15 of 58

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

Z-0883-2024
Recall number
Z-0883-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613154020133 Lot Numbers: 53867101

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 16 of 58

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

Z-0884-2024
Recall number
Z-0884-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
5 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613154020638 Lot Numbers: 42968601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 17 of 58

Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

Z-0885-2024
Recall number
Z-0885-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
9 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613154020645 Lot Numbers: 43103101

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 18 of 58

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110

Z-0886-2024
Recall number
Z-0886-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
61 units US; 46 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327050288 Lot Numbers: 79E0, 274P, WEKJ, LH82, 33ND

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 19 of 58

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510

Z-0887-2024
Recall number
Z-0887-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
76 units US;

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327050301 Lot Numbers: 57A2, 3WP6, E10K, X49N, WJ3L, 38TY,

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 20 of 58

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710

Z-0888-2024
Recall number
Z-0888-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
269 units US; 307 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327050295 Lot Numbers: RLAR, 2P84, EW6V, 90AV, 4JHN, 65A3, 22MP, NNE7, Y373, 58LA, VXAL, 4201, A2AN, 5YP8, X0P9, 9A8T,6LN7, WEL3, NDK3, 25WJ, T2JW, YVWT, 7DR0, DMVL,

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 21 of 58

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910

Z-0889-2024
Recall number
Z-0889-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
192 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327050332 Lot Numbers: X1WP, 6KE9, DL4V, HHPW, 1NL2, 4JHW, 0TNX, WN5E, 2EM2, 96N0, HW7E,T9NM, J72T, M73H, HM8H, MEM7, M8HN, WL3Y

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 22 of 58

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110

Z-0890-2024
Recall number
Z-0890-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033816 Lot Numbers: LT28, 4TXX

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 23 of 58

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710

Z-0891-2024
Recall number
Z-0891-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
36 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033847 Lot Numbers: V25H, MD9E, 5MYL, H9T8, 845P,

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 24 of 58

SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910

Z-0892-2024
Recall number
Z-0892-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
16 units US; 56 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033854 Lot Numbers: A02W, NPPV, 75TX, 6RLN

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 25 of 58

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110

Z-0893-2024
Recall number
Z-0893-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
107 units US; 176 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033861 Lot Numbers: XEA7, 8P83, 690Y, MRM3, 67D4, 4902, YNP7, 3AYN, AYHM, W3MD, 76KN, K4P9, 792H, 43T8, MW40

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 26 of 58

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308

Z-0894-2024
Recall number
Z-0894-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
1 units US; 146 units oUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033878 Lot Numbers: 2H58, 2J0W, 8H52, 64MJ, X0H9, 70E9

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 27 of 58

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508

Z-0895-2024
Recall number
Z-0895-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
137 units US; 326 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033885 Lot Numbers: EPXH, DYAE, XVK2, PVP9, LJ0K, 12R3, N8P6, T355, 8HDN, A3EV, 5LKW, R04Y, RKT1,D06K, 01JR, 3PA4, 0AYL, W424, 53T1, Y7X2,

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 28 of 58

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708

Z-0896-2024
Recall number
Z-0896-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
149 units US; 424 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033892 Lot Numbers: RDWN, 4W3T, V768, VJ05, TWT6, ADK0, 855, D6D9, TXL1, 53RN, KR24, M3T4, VE90, EKK2, 36L1, NH6E, 8PWK, R9A4, NWXA, D47L, 5JVL, D16P, E2LP, 927H, JR5N

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 29 of 58

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710

Z-0897-2024
Recall number
Z-0897-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
118 units US; 212 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033908 Lot Numbers: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, R608

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 30 of 58

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910

Z-0898-2024
Recall number
Z-0898-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
143 units US; 290 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613327033915 Lot Numbers: 73JP, V17W, N2MY, PK0D, D3M3, LEAY, 4NTR,R5WA, JN8M, 084W, K6YE, 84A4, XREK, YNM1, LY5M, M1AT, 4873

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 31 of 58

Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908

Z-0899-2024
Recall number
Z-0899-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540400734 Lot Numbers: 42874701, 42912101, 42995601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 32 of 58

Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910

Z-0900-2024
Recall number
Z-0900-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
4 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540400741 Lot Numbers: 42912201,42961901

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 33 of 58

HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J

Z-0901-2024
Recall number
Z-0901-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: n/a Lot Numbers: 38059601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 34 of 58

HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

Z-0902-2024
Recall number
Z-0902-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: n/a Lot Numbers: 29518001

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 35 of 58

HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

Z-0903-2024
Recall number
Z-0903-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: n/a Lot Numbers: 29518001

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 36 of 58

P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107

Z-0904-2024
Recall number
Z-0904-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613153076155 Lot Numbers: 61311701, 62122001

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 37 of 58

P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307

Z-0905-2024
Recall number
Z-0905-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 07613153076407 Lot Numbers: 62112001,62120801

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 38 of 58

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028

Z-0906-2024
Recall number
Z-0906-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540305831 Lot Numbers: 42771401

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 39 of 58

LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228

Z-0907-2024
Recall number
Z-0907-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306012 Lot Numbers: 54537601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 40 of 58

LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231

Z-0908-2024
Recall number
Z-0908-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306029 Lot Numbers: 42787901

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 41 of 58

LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328

Z-0909-2024
Recall number
Z-0909-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306104 Lot Numbers: 42579701

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 42 of 58

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631

Z-0910-2024
Recall number
Z-0910-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306203 Lot Numbers: 36272501,42380501 42771601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 43 of 58

RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831

Z-0911-2024
Recall number
Z-0911-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306388 Lot Numbers: 47475901

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 44 of 58

RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928

Z-0912-2024
Recall number
Z-0912-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306463 Lot Numbers: 41875401

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 45 of 58

RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931

Z-0913-2024
Recall number
Z-0913-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306470 Lot Numbers: 57403601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 46 of 58

PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031

Z-0914-2024
Recall number
Z-0914-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540306920 Lot Numbers: 36273601, 36609701

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 47 of 58

LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231

Z-0915-2024
Recall number
Z-0915-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540307101 Lot Numbers: 33164901

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 48 of 58

DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709

Z-0916-2024
Recall number
Z-0916-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540318145 Lot Numbers: 52098201, 54184201, 56002801, 50677001, 56662001

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 49 of 58

DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911

Z-0917-2024
Recall number
Z-0917-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN:04546540318299 Lot Numbers: 56000801, 57491601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 50 of 58

DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200

Z-0918-2024
Recall number
Z-0918-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540318398 Lot Numbers: 383541

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 51 of 58

DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609

Z-0919-2024
Recall number
Z-0919-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540322876 Lot Numbers: 50884601

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 52 of 58

DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611

Z-0920-2024
Recall number
Z-0920-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540322883 Lot Numbers: 52814401

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 53 of 58

DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709

Z-0921-2024
Recall number
Z-0921-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540322944 Lot Numbers: 51828501

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 54 of 58

DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711

Z-0922-2024
Recall number
Z-0922-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540322951 Lot Numbers: 52177701

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 55 of 58

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411

Z-0923-2024
Recall number
Z-0923-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540324108 Lot Numbers: 584223

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 56 of 58

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413

Z-0924-2024
Recall number
Z-0924-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540324115 Lot Numbers: 559469, 561926, 584958

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 57 of 58

PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416

Z-0925-2024
Recall number
Z-0925-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540324122 Lot Numbers: 571630, 582549, 584840

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

device · product 58 of 58

TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324

Z-0926-2024
Recall number
Z-0926-2024
Initiated
December 01, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Code information

GTIN: 04546540117144 Lot Numbers: 59065701

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.