Z-1129-2014 Class II Terminated

Recalled by MEDICAMAT S.A. — Malakoff

FDA device recall Z-1129-2014 was initiated by MEDICAMAT S.A. on February 18, 2013 and is designated Class II. Reason for recall: Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER. The recall status is terminated (terminated March 10, 2014). Affected quantity: 71 units.

Recall Details

Product Type
Devices
Report Date
March 12, 2014
Initiation Date
February 18, 2013
Termination Date
March 10, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
71 units

Product Description

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

Reason for Recall

Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.

Distribution Pattern

US Distribution including TX.

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.