Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Omni Life Science
- Reason for Recall:
- The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Product Codes/Lot Numbers:
Lot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2372-2012
Related Recalls
Incorrect lot number on outer kit
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility