BEUDAMED
    FDA Enforcement Class II Terminated

    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

    Recall: Z-1149-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1149-2020
    Event ID
    84713
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Blue Ortho
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    September 22, 2019
    Classification Date
    February 11, 2020
    Termination Date
    July 23, 2020
    Address
    6 Allee De Bethleem, Gieres, N/A, France

    Description

    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

    Reason

    The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

    Code Info

    TKA Pro v2.1 software

    Distribution

    AZ, CA, FL, TN Foreign: Italy

    Quantity

    7 units