BEUDAMED
    FDA Recall Terminated

    Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.

    Recall: Z-1993-2009 · Initiated May 29, 2009

    Recall

    Recall Number
    Z-1993-2009
    Event Number
    52423
    Firm
    Ortho Development Corporation
    FEI Number
    3017298928
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 29, 2009
    Posted
    September 9, 2009
    Terminated
    May 11, 2010
    Address
    12187 South Business Park Dr, Draper, UT, 84020

    Description

    Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability.

    Reason

    Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891).

    Action

    Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450.

    Distribution

    Worldwide -- US (states of FL and TX) and Japan.

    Quantity

    13 units