Knee Products: 141356 Regenerex Series-A Patella 3 Peg — Class II medical device recall Z-2146-2020
Terminated recall by Biomet, Inc., reported 2020-06-03, distributed nationwide. Potential presence of elevated endotoxin levels that exceed the specification limit
| Recall number | Z-2146-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-04-17 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2021-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CR, IN, JP, MX, NL, SG, TH, TW |
| Quantity | 15 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00880304506084, 00880304554412 |
| Lot numbers | 091090, 561760 |
Product
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Reason for recall
Potential presence of elevated endotoxin levels that exceed the specification limit
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-2146-2020. 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.