FDA Enforcement
Class II
Terminated
Tapered Screw-Vent MTX Model TSVTB11
Recall: Z-0284-2018
·
Reported December 27, 2017
Enforcement
- Recall Number
- Z-0284-2018
- Event ID
- 78635
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Dental Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 27, 2017
- Initiation Date
- November 20, 2017
- Classification Date
- December 21, 2017
- Termination Date
- February 28, 2024
- Address
- 1900 Aston Ave, Carlsbad, CA, 92008-7308, United States
Description
Tapered Screw-Vent MTX Model TSVTB11
Reason
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Code Info
lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
Distribution
US, Canada, France, Italy, Spain, Germany
Quantity
500 units