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U.S. Department of Health and Human Services

Class 2 Device Recall Punch Hair Matic

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 Class 2 Device Recall Punch Hair Maticsee related information
Date Initiated by FirmFebruary 18, 2013
Date PostedMarch 04, 2014
Recall Status1 Terminated 3 on March 10, 2014
Recall NumberZ-1129-2014
Recall Event ID 67421
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
ProductPunch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
Code Information 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.
FEI Number 3002642065
Recalling Firm/
Manufacturer		 MEDICAMAT S.A.
59, Avenue Augustin-Dumont
Malakoff France
Manufacturer Reason
for Recall		Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
FDA Determined
Cause 2		Labeling Change Control
ActionMEDICAMAT 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 Commerce71 units
DistributionUS Distribution including TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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