BEUDAMED
    FDA Recall Terminated

    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) 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, patello-femoral or bi-compartmental prosthesis.

    Recall: Z-2222-2012 · Initiated July 17, 2012

    Recall

    Recall Number
    Z-2222-2012
    Event Number
    62576
    Firm
    Conformis Inc
    FEI Number
    3004153240
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 17, 2012
    Posted
    August 17, 2012
    Terminated
    February 27, 2013
    Address
    1 North Ave, Suite B, Burlington, MA, 01803-3305

    Description

    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) 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, patello-femoral or bi-compartmental prosthesis.

    Reason

    Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique

    Action

    ConforMIS sent an Urgent Field Safety Notice letter dated July 5, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. An Addendum is included that provided updates to the Surgical Technique Guide. The updated technique guide will be delivered to all iTotal surgeons along with an on-site vist from ConforMIS sales representative. Customers were instructed to place the Surgical Technique Guide Addendum alongside the surgical plan, it puts the information in a highly visible location for the surgeon to review prior to the surgical procedure. Customers were asked to sign the communication verification form attached. For any questions regarding this notice, please contact your local ConforMIS representative or MDSS GmbH, Tel.: +49-511-62628630, [email protected].

    Distribution

    Worldwide Distribution - US Nationwide and the country of Germany

    Quantity

    1427 units