The Recall Desk
HighFDA (Devices)·Z-0548-2022·Announced 2022-02-09

INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled

Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with risk of malfunction. Although no injuries or illnesses have been reported, the potential for assembly failure in a medical context constitutes a risk-of-harm product, which per the severity rubric scores as High (3).

Plain-English summary

Smith & Nephew, Inc. is recalling INTEGRA SURFIX ALPHA Screwdriver Torx 10 medical device units (REF 219 135 ND) because the affected screwdrivers are out of specification and may not mate properly with the Surfix Alpha Lock screw.

The recall affects 8 units distributed in California and Ohio. The affected batch numbers are FTL9, FTLA, and FVRG. The product UDI is (01)10381780052234 (11)21101 (10)FVRG.

Healthcare facilities and providers should immediately stop using affected screwdrivers from the identified batch numbers. Contact Smith & Nephew for replacement units or disposal instructions. No injuries or illnesses have been reported related to this recall.

The recalled product

Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • assembly-failure
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category