BEUDAMED
    FDA Recall Terminated

    Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758

    Recall: Z-1010-04 · Initiated May 10, 2004

    Recall

    Recall Number
    Z-1010-04
    Event Number
    29130
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2004
    Posted
    July 20, 2004
    Terminated
    August 9, 2004
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758

    Description

    Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758

    Reason

    Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

    Action

    The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.

    Distribution

    Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.

    Quantity

    15