Z-0548-2022 Class II Ongoing
FDA device recall Z-0548-2022 was initiated by Smith & Nephew, Inc. on Jan 4, 2022 and is designated Class II. Reason for recall: The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw The recall status is ongoing. Affected quantity: 8 units (US).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units (US)
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of CA and OH.
Code Information
UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0548-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026