BEUDAMED
    FDA Recall Terminated

    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.

    Recall: Z-0411-2016 · Initiated November 24, 2015

    Recall

    Recall Number
    Z-0411-2016
    Event Number
    72714
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 24, 2015
    Posted
    December 10, 2015
    Terminated
    March 24, 2017
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.

    Reason

    Complaints that the ratchet teeth of the tube are not latching onto the rod.

    Action

    Zimmer Biomet initiated a voluntary recall of the Persona EM Proximal Tube and Persona EM Distal Rod due to complaints that the ratchet teeth of the tube are not latching onto the rod via certified mail on 11/24/2015. The firm requests customers quarantine recalled devices, return the customer response forms, and assist in returning the devices to the Zimmer Biomet sales reps. Customers with questions may contact 1-800-348-2759 between 8:00 am and 8:00 pm EST.

    Distribution

    Distributed in the states of AZ, CA, ID, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, PA, TN, TX, VA, and WA, and the country of Germany.

    Quantity

    156