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Howmedica Osteonics Corp.

Howmedica Osteonics Corp. Recalls

All product recalls associated with Howmedica Osteonics Corp..

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Recall Summary

Total Recalls

66

Past Year

2

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 66 recalls

Howmedica Osteonics Corp.: SCORPIO RECESSED PATELLA- Intended for Knee Replacement P...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: SCORPIO TS TIB INSERT -Intended for knee replacement P...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: SCORPIO U-DOME PATELLA -Intended for knee replacement ...

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.

Page 3 of 4Next

Moderate

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for k...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intend...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intend...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: PRIMARY REV.TIB.INSERT-DURACON Intended for knee repl...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: P7 28MM 10 DEGREE +4MM INSERT Intended for knee replaceme...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for kn...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee r...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee r...

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.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.

FDAMay 3, 2023IN• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended ...

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

FDAApr 13, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL),...

Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

FDAMar 10, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL),...

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

FDAMar 10, 2023Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Full Dose CE Simplex P Single Bone Cement - Indicated for...

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

FDANov 7, 2022IN• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Tobra Full Dose CE Antibiotic Simplex P- Indicated for th...

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

FDANov 7, 2022IN• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Simplex HV With Gentamicin CE, 10 PACK-Bone cement with G...

Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)

FDAOct 21, 2022Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02...

A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

FDAAug 24, 2022IN, NY• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: Triathlon Tritanium Tibial Component (Size 6); Catalog Nu...

Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

FDAMar 30, 2022Nationwide• Howmedica Osteonics Corp.