Events

Recall of Device Recall Punch Hair Matic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MEDICAMAT S.A..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67421
  • Event Risk Class
    Class 2
  • Event Number
    Z-1129-2014
  • Event Initiated Date
    2013-02-18
  • Event Date Posted
    2014-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125432
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Motor, surgical instrument, ac-powered - Product Code GEY
  • 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. .

Device

Device Recall Punch Hair Matic
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including TX.
  • Product Description
    Punch Hair Matic || A surgical hair transplant device designed for automation of follicular transplantation.
  • Manufacturer
    MEDICAMAT S.A.

Manufacturer

MEDICAMAT S.A.
  • Manufacturer Address
    MEDICAMAT S.A., 59, Avenue Augustin-Dumont, Malakoff France
  • Source
    USFDA