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Recall Observatory FDA recall evidence

Device product

QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium

Z-2909-2018

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-2909-2018

Official wording

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

Code information: 1000167017, 1000167829, 1000171360, 1000172321, 1000173866, 1000175689, 1000178993, 1000187364, 1000198471, 1000198472, 1000202431, 1000205662, 1000215879, 1000217675, 1000226524, 1000233194, 1000238414, 1000259405

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