BEUDAMED
    FDA Enforcement Class II Terminated

    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

    Recall: Z-2637-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2637-2016
    Event ID
    74850
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 31, 2016
    Initiation Date
    July 18, 2016
    Classification Date
    August 23, 2016
    Termination Date
    November 22, 2016
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703, United States

    Description

    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, 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.

    Code Info

    P239168, P239169

    Distribution

    AR, MN,MA

    Quantity

    2 units