BIOSURE HA SCREW — Class II medical device recall Z-0957-2026
Ongoing recall by Smith & Nephew, Inc., reported 2025-12-24, distributed nationwide. Removal of affected lot of screws due to labeling error.
| Recall number | Z-0957-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Mansfield, MA, United States |
| Recall initiated | 2025-11-24 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, CZ, DE, FI, FR, ID, IT, MX, MY, NL, NO, PL, SG |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00885554036572, 03596010611642 |
| Lot numbers | 51306803, 51315219 |
| Model numbers | 72201768, 72204389 |
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason for recall
Removal of affected lot of screws due to labeling error.
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-0957-2026. 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.