Device product
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Z-1243-2018
Product summary
- Event
- Event 79418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384
- Official record key
device-enforcement:Z-1243-2018
Official wording
Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information: Lot Number: 17279012 UDI: (01)4546540039415
Distribution pattern: Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Derived failure modes
-
Microbial contamination
bioburden levels were found
-
Sterility assurance
Lack of sterility