BEUDAMED
    FDA Enforcement Class II Terminated

    DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

    Recall: Z-1946-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1946-2019
    Event ID
    83024
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    May 28, 2019
    Classification Date
    July 4, 2019
    Termination Date
    November 19, 2021
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

    Reason

    There is a potential for weak seals of the sterile packaging.

    Code Info

    Lot Numbers: 235471 235472 235473 235474 235475 187762 193492 193493 193494 193495 193496 193565 BF10LBJ BFI0LBJ BFI0M9E BFI0N10 BFI0N11 BFI0P39 I0N0X I0N0XR I0N0Y I0N10 I0N11 I0N5B I0P39 225207 BFIOLBJ I0N5P

    Distribution

    Worldwide Distribution - US Nationwide: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico. Products were distributed to the following foreign countries: Australia, Canada, Chile, Japan, Netherlands.

    Quantity

    3022 total