Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI: (05055343872499, Lot Number: 529803.
- 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:
- Corin Ltd
- Reason for Recall:
- Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Product Codes/Lot Numbers:
UDI/DI: (05055343872499, Lot Number: 529803.
Distribution:
Distributed in: US, MI, TX, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0213-2024
Related Recalls
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Corin
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.