Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPI
Recalled Product
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Hazard / Issue
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Issued by
FDA
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