BEUDAMED
    FDA Enforcement Class II Terminated

    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

    Recall: Z-1610-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1610-2014
    Event ID
    68029
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Development Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 21, 2014
    Initiation Date
    April 1, 2014
    Classification Date
    May 12, 2014
    Termination Date
    July 14, 2014
    Address
    12187 Business Park Dr, Draper, UT, 84020-8663, United States

    Description

    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

    Reason

    A femoral component containing pegs was found in a box for the pegless version.

    Code Info

    Lot No. A131876

    Distribution

    US Nationwide Distribution in the states of NV, and AZ.

    Quantity

    5