Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number; PD 32 601 - ALLY Bone Screw L 10mm Lot Number: 046164 Model Number: PD 32 602 - ALLY Bone Screw L 12mm Lot Numbers: 045375 045646 045647 046313
- 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:
- PROVIDENCE MEDICAL TECHNOLOGIES
- Reason for Recall:
- There may be dimensional manufacturing error that represents a potential safety risk to patients.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.
Product Codes/Lot Numbers:
Model Number; PD 32 601 - ALLY Bone Screw L 10mm Lot Number: 046164 Model Number: PD 32 602 - ALLY Bone Screw L 12mm Lot Numbers: 045375 045646 045647 046313
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2428-2020