Device product
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Z-2914-2018
Product summary
- Event
- Event 80371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,831 total
- Official record key
device-enforcement:Z-2914-2018
Official wording
Reason: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Code information: 1000201581, 1000215163, 1000230808, 1000252564, 1000256560, 1000259410, 1000260287, 1000263504, 1000211563, 1000267011, 1000267751
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