Comprehensive Shoulder System Mini Humeral Stem — Class II medical device recall Z-0677-2022
Terminated recall by Biomet, Inc., reported 2022-03-02, distributed nationwide. The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal
| Recall number | Z-0677-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2022-01-07 |
| Classified | 2022-02-24 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2023-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, EC, NL |
| Quantity | 11 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00880304462663 |
| Lot numbers | 396250 |
| Model numbers | 113635 |
Product
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
Reason for recall
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
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-0677-2022. 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.