Device product
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
Z-0154-2015
Product summary
- Event
- Event 69392
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,044 units
- Official record key
device-enforcement:Z-0154-2015
Official wording
Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Code information: Lot No. 62659204, 62658448
Distribution pattern: Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Derived failure modes
-
Unknown
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.