Stryker Leibinger GmbH & Co. KG recalls AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
- Recall date
- June 22, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2915-2018
- 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
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
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