Device product
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Z-1255-2018
Product summary
- Event
- Event 79418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320
- Official record key
device-enforcement:Z-1255-2018
Official wording
Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information: Lot Number: 17284012 UDI: (01)4546540255853
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