DUR PCA MTK REV INS RT Intended for knee replacement Product Number:… — Class II medical device recall Z-0922-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-02-07, distributed nationwide. Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of ox
| Recall number | Z-0922-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-12-01 |
| Classified | 2024-01-31 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CH, CL, CN, DE, ES, FI, GB, HK, IE, IN, JP, KR, MX, NL, NO, NZ, PL, SE, TW |
| UPC / GTIN / UDI-DI | 04546540322951 |
| Lot numbers | 52177701 |
Product
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0922-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.