BEUDAMED
    FDA Recall 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 · Initiated August 27, 2019

    Recall

    Recall Number
    Z-2544-2019
    Event Number
    83628
    Firm
    Ad-Tech Medical Instrument Corporation
    FEI Number
    2183456
    Product Code
    HBG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 27, 2019
    Terminated
    April 5, 2023
    Address
    400 W Oakview Pkwy, Oak Creek, WI, 53154-7213

    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.

    Action

    The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.

    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