BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2242-2016 · Initiated June 21, 2016

    Recall

    Recall Number
    Z-2242-2016
    Event Number
    74484
    FEI Number
    1000116912
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 21, 2016
    Posted
    July 19, 2016
    Terminated
    January 10, 2017
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    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.

    Action

    The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.

    Distribution

    CO, ID, TX

    Quantity

    14 (7 sets)