Device product
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
Z-1250-2018
Product summary
- Event
- Event 79418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1244
- Official record key
device-enforcement:Z-1250-2018
Official wording
Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information: 1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259
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