BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1692-2020
    Event ID
    85211
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    July 10, 2018
    Classification Date
    April 10, 2020
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    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.

    Code Info

    All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.

    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)