Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
- 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:
- Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Product Codes/Lot Numbers:
Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1190-2018
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.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.