FDAFDA · Food and drugs·Recall number Z-0154-2015
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth
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. 62659204, 62658448
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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