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Recall Observatory FDA recall evidence

Device product

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium

Z-2906-2018

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-2906-2018

Official wording

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

Code information: 1000100540, 1000100541, 1000101992, 1000101994, 1000103661, 1000110486, 1000113766, 1000115217, 1000115218, 1000131912, 1000147952, 1000157990, 1000159893, 1000164241, 1000165529, 1000170706, 1000173343, 1000175688, 1000179042, 1000179720, 1000187363, 1000191064, 1000193587, 1000200400, 1000202174, 1000202430, 1000204636, 1000209030, 1000211804, 1000215160, 1000225770, 1000230169, 1000232401, 1000235430, 1000238413, 1000245177, 1000247183, 1000255708

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