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Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap St
Recalled September 5, 2018 · FDA recall Z-2899-2018 · Stryker Leibinger GmbH & Co. KG
Hazard
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. · FDA Class II
Units
22,831 total
Sold at
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Description
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
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).
Manufacturer(s)
Stryker Leibinger GmbH & Co. KG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →