Stryker Leibinger GmbH & Co. KG recalls QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
- Recall date
- June 22, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2909-2018
- 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, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Get recall alerts
Free email alert whenever Stryker Leibinger GmbH & Co. KG has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Stryker Leibinger GmbH & Co. KG