BEUDAMED
    FDA Enforcement Class II 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 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0165-2016
    Event ID
    72216
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    September 16, 2015
    Classification Date
    October 26, 2015
    Termination Date
    January 4, 2016
    Address
    9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States

    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.

    Code Info

    471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008

    Distribution

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

    Quantity

    209 units