A — Class II medical device recall Z-0882-2021
Terminated recall by Biomet, Inc., reported 2021-01-27, distributed nationwide. The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This
| Recall number | Z-0882-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-12-23 |
| Classified | 2021-01-21 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2023-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 174 systems |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00880304834644 |
| Lot numbers | 516349, 545167 |
| Model numbers | 233500004 |
Product
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Reason for recall
The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
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-0882-2021. 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.