FDA-Device2018-09-05Class II
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
Hazard
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Sold states
US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
Affected count
22,831 total
Manufactured in
Botzinger Str. 41, N/A, Freiburg Im Breisgau, N/A, Germany
Products
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2903-2018Don't want to check this manually?
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