BEUDAMED
    FDA Recall Open, Classified

    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

    Recall: Z-1692-2020 · Initiated July 10, 2018

    Recall

    Recall Number
    Z-1692-2020
    Event Number
    85211
    FEI Number
    1000116912
    Product Code
    LPH
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    July 10, 2018
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    Description

    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

    Reason

    The retaining ring on the neck trials has a potential to fail interoperatively.

    Action

    The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall.

    Distribution

    Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.

    Quantity

    28 (14 REF S200635 and 14 S200636)