🔍 RecallPedia

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Class I - Dangerous
🏥 Medical Devices Recalled: January 4, 2022 Smith & Nephew Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: (01)10381780052234 (11)21101 (10)FVRG, Batch Numbers: FTL9, FTLA, and FVRG
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smith & Nephew, Inc.
Reason for Recall:
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0548-2022

Related Recalls

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

Mar 18, 2025 Other Medical Devices Nationwide View Details →