BEUDAMED
    FDA Enforcement Class II Ongoing

    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

    Recall: Z-0041-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0041-2024
    Event ID
    93046
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Blue Belt Technologies, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    September 7, 2023
    Classification Date
    October 5, 2023
    Address
    2875 Railroad St, N/A, Pittsburgh, PA, 15201, United States

    Description

    Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

    Reason

    CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis

    Code Info

    UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689

    Distribution

    US Nationwide distribution.

    Quantity

    56 units