BEUDAMED
    FDA Recall Terminated

    Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.

    Recall: Z-0331-06 · Initiated November 3, 2005

    Recall

    Recall Number
    Z-0331-06
    Event Number
    33991
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2005
    Posted
    December 29, 2005
    Terminated
    April 4, 2008
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.

    Reason

    The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

    Action

    Firm initiated recall on 11/03/05 via letter to all consignees.

    Distribution

    Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.

    Quantity

    16 units.