BEUDAMED
    FDA Recall Terminated

    ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)

    Recall: Z-0145-2016 · Initiated August 31, 2015

    Recall

    Recall Number
    Z-0145-2016
    Event Number
    72108
    Firm
    ConforMIS, Inc.
    FEI Number
    3009844603
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 31, 2015
    Posted
    October 21, 2015
    Terminated
    March 2, 2016
    Address
    28 Crosby Dr, Bedford, MA, 01730-1402

    Description

    ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)

    Reason

    May contain small amounts of ethylene glycol residue

    Action

    ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.

    Distribution

    Distributed Nationwide and in Germany, Switzerland, and UK.

    Quantity

    313 units