BEUDAMED
    FDA Recall Terminated

    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

    Recall: Z-2539-2018 · Initiated May 2, 2018

    Recall

    Recall Number
    Z-2539-2018
    Event Number
    80280
    Firm
    Ad-Tech Medical Instrument Corporation
    FEI Number
    2183456
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 2, 2018
    Terminated
    February 8, 2019
    Address
    400 W Oakview Pkwy, Oak Creek, WI, 53154-7213

    Description

    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

    Reason

    The 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

    Customers were notified on 05/02/2018 via a MEDICAL DEVICE RECALL letter. Instructions included to immediately examine your inventory and quarantine any product subject to recall and replacement. Customers/distributors who received affected devices will be contacted to return their unopened/unused and/or reused stock of the affected product.

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, MI, NH, NY, OH, OR, PA, SC, UT, WV. Worldwide distribution to Canada, Denmark, Germany, India, Israel, Japan, Russia, South Korea, Taiwan, United Kingdom.

    Quantity

    65 Total