BEUDAMED
    FDA Recall 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 · Initiated September 22, 2019

    Recall

    Recall Number
    Z-1149-2020
    Event Number
    84713
    FEI Number
    3008027912
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 22, 2019
    Terminated
    July 23, 2020
    Address
    Blue Ortho 6 Allee De Bethleem Gieres 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).

    Action

    Blue Ortho issued an Advisory Notice via email on September 22, 2019 stating the reason for recall, health risk and action to take: The issue happens only with the LPI instrumentation. There is no issue with the Truliant instrumentation. Therefore, Blue Ortho ask the user: To use the TKA Pro 2.1 software application with the Truliant instrumentation only, To NOT change the instrumentation once the protocol is started. Do not click on Change instrument nor Change to LPI.If the Truliant instrumentation is not available, the TKA Pro 2.1 software application must not be used. Blue Ortho will deliver a new software version correcting this issue.

    Distribution

    AZ, CA, FL, TN Foreign: Italy

    Quantity

    7 units