BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050

    Recall: Z-0780-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0780-2020
    Event ID
    84458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2020
    Initiation Date
    December 5, 2019
    Classification Date
    January 7, 2020
    Termination Date
    October 9, 2020
    Address
    Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland

    Description

    Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050

    Reason

    Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.

    Code Info

    All lots UDI: (01)07613327350210

    Distribution

    Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.

    Quantity

    433 (289 units U.S. / 144 units OUS)