Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517
  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:
Synthes USA HQ, Inc.
Reason for Recall:
The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Product Codes/Lot Numbers:

Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0407-2014

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