BEUDAMED
    FDA Enforcement Class II Terminated

    iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

    Recall: Z-1108-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1108-2019
    Event ID
    82100
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 17, 2019
    Initiation Date
    December 3, 2018
    Classification Date
    April 8, 2019
    Termination Date
    June 26, 2020
    Address
    600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

    Reason

    The kits were prepared with incorrect patient ID labels and may contain incorrect components.

    Code Info

    Serial Numbers 0432428 and 0432212

    Distribution

    Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.

    Quantity

    2