Tapered SwissPlus Implant System, Model No. SPB10
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
- 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:
- Zimmer Dental Inc
- Reason for Recall:
- It was manufactured with the minor diameter of the internal thread that is below specification.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tapered SwissPlus Implant System, Model No. SPB10
Product Codes/Lot Numbers:
Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
Distribution:
Distributed in: ZA, FR, IT, IR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1823-2017
Related Recalls
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.