BEUDAMED
    FDA Enforcement Class II Terminated

    ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.

    Recall: Z-0658-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0658-2017
    Event ID
    75553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConforMIS, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 7, 2016
    Initiation Date
    October 18, 2016
    Classification Date
    November 25, 2016
    Termination Date
    December 7, 2016
    Address
    28 Crosby Dr, Bedford, MA, 01730-1402, United States

    Description

    ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.

    Reason

    Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

    Code Info

    Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

    Distribution

    Distributed to the states of CO and NV.

    Quantity

    2 units