Z-2898-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- June 22, 2018
- Termination Date
- July 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,831 total
Product Description
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).
Reason for Recall
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Distribution Pattern
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Code Information
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