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Recall Observatory FDA recall evidence

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

June 22, 2018

Class II

Product summary

Firm
Stryker Leibinger GmbH & Co. KG
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

    reason.sterility_assurance · v1.0.0

    sterile barrier) to become compromised