BEUDAMED
    FDA Recall Terminated

    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

    Recall: Z-0970-2015 · Initiated December 1, 2014

    Recall

    Recall Number
    Z-0970-2015
    Event Number
    70082
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 1, 2014
    Posted
    January 14, 2015
    Terminated
    May 6, 2015
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    Description

    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

    Reason

    Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.

    Action

    On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory.

    Distribution

    TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.

    Quantity

    553