BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

    Recall: Z-0027-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0027-2016
    Event ID
    72121
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    August 11, 2015
    Classification Date
    October 6, 2015
    Termination Date
    March 15, 2016
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

    Reason

    It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat

    Code Info

    Item No. 00-4836-080-00; Lot 56555128

    Distribution

    Distributed in NC, AL, KS, TX, UT, CA, and SINGAPORE.

    Quantity

    18 units