Z-1129-2014Class II

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

Name: Z-1129-2014 Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation
Creator: Medicamat S.a.
Published: 2013-02-18
License: https://open.fda.gov/license/

Medicamat S.A. / initiated 2013-02-18 / Terminated / root cause: labeling and UDI

FDA source

MEDICAMAT S.A. began a recall of Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation on 2013-02-18. FDA classified it as Class II and gives the reason as "Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1129-2014
Classification: Class II
Status: Terminated
Initiated: 2013-02-18
Posted: 2014-03-04
Terminated: 2014-03-10
Recalling firm: Medicamat S.A.
Product: Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
Product code: GEY Motor, Surgical Instrument, Ac-Powered
Reason for recall: Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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. .
Quantity in commerce: 71 units
Distribution: US Distribution including TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1129-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code GEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)