BEUDAMED
    FDA Enforcement Class II Terminated

    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

    Recall: Z-2242-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2242-2016
    Event ID
    74484
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    June 21, 2016
    Classification Date
    July 19, 2016
    Termination Date
    January 10, 2017
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    Description

    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

    Reason

    Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

    Code Info

    Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901

    Distribution

    CO, ID, TX

    Quantity

    14 (7 sets)