Device product
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Z-2911-2018
Product summary
- Event
- Event 80371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,831 total
- Official record key
device-enforcement:Z-2911-2018
Official wording
Reason: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Code information: 1000201582, 1000254804, 1000258650, 1000259408, 1000261022, 1000262518, 1000262519
Distribution pattern: US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Derived failure modes
-
Sterility assurance
sterile barrier) to become compromised