Device product
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Z-2915-2018
Product summary
- Event
- Event 80371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,831 total
- Official record key
device-enforcement:Z-2915-2018
Official wording
Reason: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Code information: 1000201577, 1000215164, 1000218602, 1000248070, 1000254405, 1000261028, 1000262520, 1000264409, 1000266168, 1000288211, 1000289258, 1000292117
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