BEUDAMED
    FDA Enforcement Class II Terminated

    AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N

    Recall: Z-2544-2019 · Reported September 25, 2019

    Enforcement

    Recall Number
    Z-2544-2019
    Event ID
    83628
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ad-Tech Medical Instrument Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2019
    Initiation Date
    August 27, 2019
    Classification Date
    September 13, 2019
    Termination Date
    April 5, 2023
    Address
    400 W Oakview Pkwy, N/A, Oak Creek, WI, 53154-7213, United States

    Description

    AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N

    Reason

    The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.

    Code Info

    All serial numbers distributed between January 2014 and May 2019

    Distribution

    NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France

    Quantity

    315 units