BEUDAMED
    FDA Enforcement Class II Terminated

    DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

    Recall: Z-1947-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1947-2019
    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 Depth Gauge, Model Number 212000003 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: 226646 230493 231877 232682 235476 BFI0LBKR 187763 193566 BF10LBK BFA012345 BFI0LBK BFI0M4H BFI0M9F BFI0N13 BFI0N14 BFION15 I0N12 I0N12R I0N13 BF10M9F BFIOLBK

    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