REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006
- 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:
- Osteomed, LLC
- Reason for Recall:
- Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Product Codes/Lot Numbers:
Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2108-2023
Related Recalls
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
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