6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number 10-55-025, Lot Number 006A1057.
- 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:
- Encore Medical, Lp
- Reason for Recall:
- A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Product Codes/Lot Numbers:
Model Number 10-55-025, Lot Number 006A1057.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0139-2013
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