medical Class II Updated 2018-09-05

Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILL

Recalled Product

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S 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

Affected States: AZ, FL, NH, OH

Lot/Code Info: 1000085083, 1000089303, 1000089990, 1000095193, 1000100539, 1000104523, 1000107792, 1000110518, 1000116215, 1000124115, 1000129492, 1000134144, 1000139985, 1000146194, 1000151496, 1000156358, 1000164801, 1000167015, 1000170704, 1000174837, 1000178195, 1000181123, 1000183608, 1000188543, 1000192851, 1000197301, 1000209029, 1000219395, 1000221066, 1000237512, 1000239649, 1000240995, 1000251376, 1000259411, 1000275865, 1000286361, 1000290245

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