FDA recall Z-2915-2018

Stryker Leibinger GmbH & Co. KG · Class II · device

Product

AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-06-22
Report date
2018-09-05
Termination date
2019-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Freiburg Im Breisgau, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2915-2018