BEUDAMED
    FDA Recall 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 · Initiated April 1, 2014

    Recall

    Recall Number
    Z-1610-2014
    Event Number
    68029
    Firm
    Ortho Development Corporation
    FEI Number
    3017298928
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 1, 2014
    Posted
    May 13, 2014
    Terminated
    July 14, 2014
    Address
    12187 Business Park Dr, Draper, UT, 84020-8663

    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.

    Action

    Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.

    Distribution

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

    Quantity

    5