BEUDAMED
    FDA Recall Terminated

    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

    Recall: Z-2635-2016 · Initiated July 18, 2016

    Recall

    Recall Number
    Z-2635-2016
    Event Number
    74850
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 18, 2016
    Terminated
    November 22, 2016
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

    Reason

    The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

    Action

    On 07/18/2016, the firm initiated the correction by verbally notifying (by visit and telephone) three of four (3 of 4) implanting surgeons; the fourth implanting surgeon was verbally notified on 07/25/2016. The firm followed with a letter to all four (4) surgeons on 07/28/2016. Medtronic recommended that the condition of the patients receiving the subject part be assessed for any indications of premature failure during normal post-operative follow-up visits.

    Distribution

    AR, MN,MA

    Quantity

    3 units