Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
FDA Recall Z-1129-2014 · Posted 2014-03-04
Recalling FirmMEDICAMAT S.A.
Recall StatusTerminated
Product CodeGEY
Date Initiated2013-02-18
Date Terminated2014-03-10
Product Quantity71 units
Reason for Recall
Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
Firm 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.
.
Root Cause
Labeling Change Control
Distribution Pattern
US Distribution including TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.