Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
- 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:
- INCIPIO DEVICES
- Reason for Recall:
- Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Product Codes/Lot Numbers:
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0549-2025