Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Ste…

Recall date

June 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2898-2018

FDA classification

Class II

Brand / firm

Stryker Leibinger GmbH & Co. KG

Sold / distributed

US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.

Why it was recalled

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).