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Recall Observatory FDA recall evidence

Device product

AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium

Z-2910-2018

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-2910-2018

Official wording

Reason: After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Code information: 1000201514, 1000203740, 1000216825, 1000220166, 1000233195, 1000237514, 1000238415, 1000245178, 1000252563, 1000254189, 1000254403, 1000255709, 1000256557, 1000257448, 1000258647, 1000258648, 1000258649, 1000259406, 1000259407, 1000260281, 1000260282, 1000261023, 1000261024, 1000261687, 1000261688, 1000262515, 1000262516, 1000262517, 1000263497, 1000264403, 1000264404, 1000264405, 1000265422, 1000268571, 1000268572, 1000201514, 1000287394, 1000292115, 1000293285,

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