Class II — Smith & Nephew, Inc.
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw |
| Product | INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND |
| Quantity | 8 units (US) |
| Distribution | US Nationwide distribution in the states of CA and OH. |
| Initiated | 2022-01-04 |
| Classified | 2022-02-01 |
| Recall number | Z-0548-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Smith & Nephew, Inc. (Z-0548-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89382/
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