BEUDAMED
    FDA Enforcement Class II Terminated

    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.

    Recall: Z-0410-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0410-2016
    Event ID
    72714
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2015
    Initiation Date
    November 24, 2015
    Classification Date
    December 10, 2015
    Termination Date
    March 24, 2017
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.

    Reason

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

    Code Info

    Proximal Tube Item Number 42-5399-001-00, Lots: 2137111, 62156913, 62222598.

    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