BEUDAMED
    FDA Recall 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 · Initiated November 19, 2014

    Recall

    Recall Number
    Z-0581-2015
    Event Number
    69867
    Firm
    ConforMIS, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 19, 2014
    Posted
    December 11, 2014
    Terminated
    October 8, 2015
    Address
    28 Crosby Dr, Bedford, MA, 01730-1402

    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

    Action

    Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.

    Distribution

    Distributed to IN.

    Quantity

    1 unit