BEUDAMED
    FDA Enforcement Class II Ongoing

    Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.

    Recall: Z-1904-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1904-2020
    Event ID
    85157
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho Development Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 13, 2020
    Initiation Date
    May 30, 2019
    Classification Date
    May 5, 2020
    Address
    12187 S Business Park Dr, N/A, Draper, UT, 84020-8663, United States

    Description

    Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.

    Reason

    The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.

    Code Info

    Lot Number: A204324

    Distribution

    US: CA, FL, OH, PA, TX, and UT. OUS: Japan.

    Quantity

    29