Recall Z-1129-2014 ยท GEY Motor, Surgical Instrument, Ac-Powered
MEDICAMAT S.A.
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
| Date | Mar 4, 2014 (initiated Feb 18, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.