BEUDAMED
    FDA Enforcement Class II Terminated

    iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - 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-1627-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1627-2020
    Event ID
    85108
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 8, 2020
    Initiation Date
    February 3, 2020
    Classification Date
    April 1, 2020
    Termination Date
    December 2, 2020
    Address
    600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States

    Description

    iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - 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

    A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

    Code Info

    0454572 0454472 0459726 0449726

    Distribution

    US Nationwide distribution in the states of LA, NY, TN.

    Quantity

    4