Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;
- 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:
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for Recall:
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Product Codes/Lot Numbers:
Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1517-2026
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