Oxford Partial Knee System — Class II medical device recall Z-1018-2023
Ongoing recall by Biomet, Inc., reported 2023-02-01, distributed nationwide. Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required oute
| Recall number | Z-1018-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-26 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, NL, NZ |
| Quantity | 7 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 05019279515349 |
| Lot numbers | 077830 |
| Model numbers | 154341 |
Product
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Reason for recall
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
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-1018-2023. 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.