BEUDAMED
    FDA Enforcement Class II Terminated

    ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS 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-0991-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0991-2017
    Event ID
    75969
    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
    January 18, 2017
    Initiation Date
    October 31, 2016
    Classification Date
    January 10, 2017
    Termination Date
    January 11, 2017
    Address
    28 Crosby Dr, Bedford, MA, 01730-1402, United States

    Description

    ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS 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

    iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

    Code Info

    Serial Number: 0384180

    Distribution

    Distribution to TX only

    Quantity

    1 unit