BEUDAMED
    FDA Enforcement Class II Terminated

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

    Recall: Z-1070-2016 · Reported March 16, 2016

    Enforcement

    Recall Number
    Z-1070-2016
    Event ID
    73246
    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
    March 16, 2016
    Initiation Date
    January 28, 2016
    Classification Date
    March 8, 2016
    Termination Date
    March 9, 2016
    Address
    28 Crosby Dr, N/A, Bedford, MA, 01730-1402, United States

    Description

    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

    Reason

    Incorrect femoral component distributed

    Code Info

    Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108

    Distribution

    KY

    Quantity

    1 unit