FDAClass IIFebruary 9, 2022

INTEGRA SURFIX ALPHA Screwdriver Torx 10 recall

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Why was INTEGRA SURFIX ALPHA Screwdriver Torx 10 recalled?

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG

Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Recalling firm
Smith & Nephew, Inc.
Quantity
8 units (US)
Distribution
US Nationwide distribution in the states of CA and OH.
Recall date
February 9, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls