BEUDAMED
    FDA Enforcement Class II Terminated

    Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

    Recall: Z-3240-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3240-2018
    Event ID
    80863
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    July 26, 2018
    Classification Date
    September 22, 2018
    Termination Date
    May 26, 2020
    Address
    Bohnackerweg 1, Selzach, N/A, Switzerland

    Description

    Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

    Reason

    When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.

    Code Info

    Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

    Distribution

    Nationwide

    Quantity

    233