INTEGRA SURFIX ALPHA Screwdriver Torx 10 — Class II medical device recall Z-0548-2022
Ongoing recall by Smith & Nephew, Inc., reported 2022-02-09, distributed nationwide. The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
| Recall number | Z-0548-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2022-01-04 |
| Classified | 2022-02-01 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10381780052234 |
| Lot numbers | FTL9 |
| Model numbers | 135ND, 219 |
Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Reason for recall
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
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-0548-2022. 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.