BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

    Recall: Z-2219-2024 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2219-2024
    Event ID
    94721
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2024
    Initiation Date
    May 9, 2024
    Classification Date
    June 27, 2024
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

    Reason

    The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

    Code Info

    Lot #J43995, UDI-DI 07613252611035.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.

    Quantity

    39 devices