BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1129-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1129-2014
    Event ID
    67421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDICAMAT S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 12, 2014
    Initiation Date
    February 18, 2013
    Classification Date
    March 4, 2014
    Termination Date
    March 10, 2014
    Address
    59, Avenue Augustin-Dumont, Malakoff, N/A, France

    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.

    Code Info

    Serial numbers of units distributed from October 16, 2012 to December 18, 2013: 189,190,191,192,193,207,208,209,210,211,212,213,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,235,236,237,238,244,245,246,247,248,249,264,265,266,267,268,269,270,271,272,273,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299.

    Distribution

    US Distribution including TX.

    Quantity

    71 units