Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842:
  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. Endoscopy Division
Reason for Recall:
Distal part of the anchor may break on insertion into bone during surgery
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618

Product Codes/Lot Numbers:

Lot Numbers: 50396501, 50396505, 50396506, 50397570, 50408062, 50412964, 50416842:

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2165-2012

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