Z-2899-2018 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 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).
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
1000193584