BEUDAMED
    FDA Recall Terminated

    Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.

    Recall: Z-2734-2011 · Initiated April 21, 2011

    Recall

    Recall Number
    Z-2734-2011
    Event Number
    58678
    FEI Number
    1000116912
    Product Code
    HTQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 21, 2011
    Posted
    July 5, 2011
    Terminated
    April 6, 2012
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.

    Reason

    Strike plate may dislodge from the broach stem handle during impaction of the device.

    Action

    Encore Medical, Lp (d.b.a. DJO Global) sent out a "Urgent Field Safety Notice" dated April 20, 2011 to all affected customers. The firm also e-mailed the consignees as well. The letter described the product, affected lots, reason for recall and provided recommendations including; asking customers contact firm for a replacement, provided a "Field Safety Response Form" to fill out and return. The firm also e-mailed the consignees as well. For additional information please contact the Director of Commercial Logistics at (512) 834-6330 or the International Customer Service at 512 834-6275.

    Distribution

    Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan.

    Quantity

    15 units