SURFIX recallZ-0548-2022 · Smith & Nephew, Inc. · initiated Jan 4, 2022
Class II Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA root cause category: Process control
What the company is doing
The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.
Recall details
- Recall number
- Z-0548-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 4, 2022
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 8 units (US)
- Product code
- HRS
- FDA submissions
- K073375
- Distribution
- US Nationwide distribution in the states of CA and OH.
Product description
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Code information (models, lots, serial numbers)
UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SURFIX® 219135NDNewdeal · SCREWDRIVER1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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