Recall Z-1129-2014
Medicamat S.A. · initiated February 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
Codes / 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.
Reason for recall
Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
FDA-determined cause: Labeling Change Control
Action taken
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. .
Details
- Recall number
- Z-1129-2014
- Initiated
- February 18, 2013
- Posted by FDA
- March 4, 2014
- Terminated
- March 10, 2014
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Quantity
- 71 units
- Distribution
- US Distribution including TX.
- Recalling firm
- Medicamat S.A., Malakoff