🔍 RecallPedia

Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

Class I - Dangerous
🏥 Medical Devices Recalled: June 9, 2015 Omnilife Science Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: MM0314R, VA0713, Z1111
  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:
Omnilife Science Inc.
Reason for Recall:
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

Product Codes/Lot Numbers:

Lot Numbers: MM0314R, VA0713, Z1111

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2454-2015

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