BEUDAMED
    FDA Enforcement Class II Terminated

    AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium

    Recall: Z-2913-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2913-2018
    Event ID
    80371
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Leibinger GmbH & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    June 22, 2018
    Classification Date
    August 29, 2018
    Termination Date
    July 8, 2019
    Address
    Botzinger Str. 41, N/A, Freiburg Im Breisgau, N/A, N/A, Germany

    Description

    AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium

    Reason

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

    Code Info

    1000201635, 1000215162, 1000230807, 1000236134, 1000253512, 1000256558, 1000258653, 1000260286, 1000263503, 1000261692, 1000265425, 1000265426

    Distribution

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

    Quantity

    22,831 total