BEUDAMED
    FDA Recall Terminated

    Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551

    Recall: Z-1255-2010 · Initiated February 22, 2010

    Recall

    Recall Number
    Z-1255-2010
    Event Number
    54702
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 22, 2010
    Posted
    April 7, 2010
    Terminated
    July 22, 2010
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551

    Reason

    One lot of product was incorrectly manufactured. Pegs are larger than specification.

    Action

    Firm notified consignees by e-mail on 2/22/2010.

    Distribution

    United States (FL and ID).

    Quantity

    2 units