BEUDAMED
    FDA Recall Terminated

    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

    Recall: Z-0165-2016 · Initiated September 16, 2015

    Recall

    Recall Number
    Z-0165-2016
    Event Number
    72216
    FEI Number
    1000116912
    Product Code
    OIY
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 16, 2015
    Posted
    October 26, 2015
    Terminated
    January 4, 2016
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

    Reason

    The labeling is missing the size/diameter information.

    Action

    DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.

    Distribution

    US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.

    Quantity

    209 units