BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

    Recall: Z-1938-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1938-2018
    Event ID
    80002
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ad-Tech Medical Instrument Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    December 20, 2017
    Classification Date
    May 25, 2018
    Termination Date
    October 12, 2018
    Address
    400 W Oakview Pkwy, N/A, Oak Creek, WI, 53154-7213, United States

    Description

    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame.

    Reason

    There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits, Lot Number 111745 208140649 and vice versa.

    Code Info

    Catalog No. DDK2-2.4-30X, Lot No. 0111664 208140649, UDI No. 01008418231011741719080110011174 5208140649; Catalog No. DDK2-2.8-30X, Lot No. 0111745 208140649, UDI No. 01008418231011671719080110011166 4208140649

    Distribution

    Worldwide Distribution: US (nationwide) to states of: CA, DC, FL, MI, MA, NC, NY, WA, WI; and country of: Canada. Distributed internationally to the United Kingdom.

    Quantity

    30 devices