BEUDAMED
    FDA Enforcement Class II Terminated

    Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

    Recall: Z-0581-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0581-2015
    Event ID
    69867
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConforMIS, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 17, 2014
    Initiation Date
    November 19, 2014
    Classification Date
    December 10, 2014
    Termination Date
    October 8, 2015
    Address
    28 Crosby Dr, N/A, Bedford, MA, 01730-1402, United States

    Description

    Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.

    Reason

    Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting

    Code Info

    Serial Number: 0340552

    Distribution

    Distributed to IN.

    Quantity

    1 unit