BEUDAMED
    FDA Recall Terminated

    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium

    Recall: Z-2901-2018 · Initiated June 22, 2018

    Recall

    Recall Number
    Z-2901-2018
    Event Number
    80371
    Firm
    Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
    FEI Number
    3002821504
    Product Code
    GWO
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 22, 2018
    Terminated
    July 8, 2019

    Description

    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium

    Reason

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

    Action

    URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to [email protected]. 4. Keep a copy of the completed and executed Customer response Form for your records.

    Distribution

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

    Quantity

    22,831 total