🔍 RecallPedia

TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor

Class I - Dangerous
🏥 Medical Devices Recalled: August 6, 2013 Smith & Nephew, Inc. Endoscopy Division Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    50373721 50375642 50397595 50397598 50397604 50397607 50449548
  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:
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor

Product Codes/Lot Numbers:

50373721 50375642 50397595 50397598 50397604 50397607 50449548

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2240-2013

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