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Recall Observatory FDA recall evidence

Device product

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

Z-1129-2014

February 18, 2013

Class II

Product summary

Firm
MEDICAMAT S.A.
Event
Event 67421
Status
Terminated
Classification
Class II
Quantity
71 units
Official record key
device-enforcement:Z-1129-2014

Official wording

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

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.

Distribution pattern: US Distribution including TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    misbranded