FDAFDA · Food and drugs·Recall number Z-0153-2015
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.
Published November 5, 2014 · Recall initiated: October 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Dental Inc
- Distributor
- Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
- Lot
- Lot No. 61792330
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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