FDA Enforcement
Class II
Terminated
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
Recall: Z-0154-2015
·
Reported November 5, 2014
Enforcement
- Recall Number
- Z-0154-2015
- Event ID
- 69392
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Dental Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2014
- Initiation Date
- October 1, 2014
- Classification Date
- October 30, 2014
- Termination Date
- April 28, 2015
- Address
- 1900 Aston Ave, N/A, Carlsbad, CA, 92008-7308, United States
Description
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
Reason
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Code Info
Lot No. 62659204, 62658448
Distribution
Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Quantity
1,044 units