BEUDAMED
    FDA Enforcement Class II Terminated

    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium

    Recall: Z-2909-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2909-2018
    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

    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, 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

    1000167017, 1000167829, 1000171360, 1000172321, 1000173866, 1000175689, 1000178993, 1000187364, 1000198471, 1000198472, 1000202431, 1000205662, 1000215879, 1000217675, 1000226524, 1000233194, 1000238414, 1000259405

    Distribution

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

    Quantity

    22,831 total