BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved

    Recall: Z-1191-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1191-2023
    Event ID
    91666
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2023
    Initiation Date
    February 7, 2023
    Classification Date
    March 1, 2023
    Address
    Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland

    Description

    stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved

    Reason

    Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.

    Code Info

    Serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713, G16331, G16332, G16333, G26278, G29759, G29760, G32730, G32731, G32735, G45119, H30398, H30399, H66392

    Distribution

    US Nationwide distribution.

    Quantity

    488 units