BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.

    Recall: Z-1238-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1238-2013
    Event ID
    64771
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    February 22, 2013
    Classification Date
    May 3, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.

    Reason

    The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.

    Code Info

    All Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628.

    Distribution

    Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.

    Quantity

    417