PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. A131876
- 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:
- Ortho Development Corporation
- Reason for Recall:
- A femoral component containing pegs was found in a box for the pegless version.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Product Codes/Lot Numbers:
Lot No. A131876
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1610-2014
Related Recalls
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Ortho Development
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
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