🔍 RecallPedia

TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor

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

What Should You Do?

  1. Check if you have this product:
    50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472
  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 HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor

Product Codes/Lot Numbers:

50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2230-2013

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