FDA Device recall Z-0548-2022
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
- FDA Device
- Class II
- ongoing
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND by Smith And Nephew, citing the affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0548-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-04 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Reason
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Identifiers
| code_info | UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.