Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot No. 61792330
- 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:
- Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
Product Codes/Lot Numbers:
Lot No. 61792330
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0153-2015
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.