BEUDAMED
    FDA Recall Terminated

    EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

    Recall: Z-0009-2008 · Initiated August 9, 2007

    Recall

    Recall Number
    Z-0009-2008
    Event Number
    38951
    FEI Number
    1000116912
    Product Code
    HRY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 9, 2007
    Posted
    October 10, 2007
    Terminated
    March 10, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

    Reason

    Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

    Action

    Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.

    Distribution

    Products distributed to direct accounts in CA, FL and MD.

    Quantity

    5 units.