BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1070-2016 · Initiated January 28, 2016

    Recall

    Recall Number
    Z-1070-2016
    Event Number
    73246
    Firm
    ConforMIS, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 28, 2016
    Terminated
    March 9, 2016
    Address
    28 Crosby Dr, Bedford, MA, 01730-1402

    Description

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

    Reason

    Incorrect femoral component distributed

    Action

    Conformis notiifed the surgeon via the sales rep on 1/28/16 of the error and the correct femoral component was processed. The surgeon received it on February 1, 2016.

    Distribution

    KY

    Quantity

    1 unit