A — Class II medical device recall Z-2058-2015
Terminated recall by Biomet, Inc., reported 2015-07-22. Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
| Recall number | Z-2058-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-07-10 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-03-22 |
| Countries outside the US | JP, NL |
| Quantity | 50 units |
| Reason classes | sterility |
| Lot numbers | 061300 |
| Model numbers | 856135060 |
Product
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Reason for recall
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
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-2058-2015. 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.