Device product
Tapered Screw-Vent MTX Model TSVTB11
Z-0284-2018
Product summary
- Event
- Event 78635
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 units
- Official record key
device-enforcement:Z-0284-2018
Official wording
Reason: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Code information: lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
Distribution pattern: US, Canada, France, Italy, Spain, Germany
Derived failure modes
-
Unknown
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.