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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1129-2014
Recalling firm
MEDICAMAT S.A.
Product
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
Status
Terminated
Initiated
2013-02-18
Posted
2014-03-04
Terminated
2014-03-10
Reason
Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
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
71 units
Distribution
US Distribution including TX.
Lot, serial or model codes
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.
510(k) numbers
not on file
PMA numbers
not on file
Product code
GEY
Firm FEI
3002642065
Firm city
Malakoff
Firm state
not on file
Firm country
France

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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