BEUDAMED
    FDA Enforcement Class II Terminated

    ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111

    Recall: Z-0144-2016 · Reported October 28, 2015

    Enforcement

    Recall Number
    Z-0144-2016
    Event ID
    72108
    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
    October 28, 2015
    Initiation Date
    August 31, 2015
    Classification Date
    October 21, 2015
    Termination Date
    March 2, 2016
    Address
    28 Crosby Dr, N/A, Bedford, MA, 01730-1402, United States

    Description

    ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111

    Reason

    May contain small amounts of ethylene glycol residue

    Code Info

    Serial Numbers (US): 0354697, 0353789, 0354533

    Distribution

    Distributed Nationwide and in Germany, Switzerland, and UK.

    Quantity

    3 units