BEUDAMED
    FDA Recall Terminated

    Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.

    Recall: Z-1129-2014 · Initiated February 18, 2013

    Recall

    Recall Number
    Z-1129-2014
    Event Number
    67421
    Firm
    MEDICAMAT S.A. 59, Avenue Augustin-Dumont Malakoff France
    FEI Number
    3002642065
    Product Code
    GEY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    February 18, 2013
    Posted
    March 4, 2014
    Terminated
    March 10, 2014

    Description

    Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.

    Reason

    Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.

    Action

    MEDICAMAT sent an Advisory Notice dated May 7, 2013, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The notification advises customers of the issue (misbranded brochure and website). The letter advises the distributor to delete the misbranded language from their communication, marketing, or other information provided to clients. They are also advised to ask their clients change their marketing if necessary and provided corrective labeling. For further questions please call +33146562404. .

    Distribution

    US Distribution including TX.

    Quantity

    71 units