Copeland HA Resurfacing Head — Class II medical device recall Z-0527-2020
Terminated recall by Zimmer Biomet, Inc., reported 2019-12-04, distributed nationwide. Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
| Recall number | Z-0527-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-08-21 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2021-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CO, CR, EC, IN, IT, JP, KR, MX, MY, NL, NZ, PA, SG, SV, TH, TT, TW, VE |
| Quantity | 219,988 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00880304204751, 00880304204768, 00880304204775, 00880304204782, 00880304204799, 00880304204805, 00880304204812, 00880304204829, 00880304439894, 00880304439900, 00880304439917, 00880304439924, 00880304439931, 00880304439948, 00880304439955, 00880304439962, 00887868346934 |
| Model numbers | 11-114632, 11-114633, 11-114641, 11-114642, 11-114643, 11-114644, 11-114644S, 11-114645, 11-114646, 11-114647, 11-114648, 11-114661, 11-114662, 11-114663, 11-114664, 11-114664S, 11-114665, 11-114666, 11-114667, 11-114668 |
Product
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
Reason for recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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-0527-2020. 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.