FDADecember 30, 2019device
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
What to do
FDA enforcement status: Terminated
Brands named
solta medicalsolta
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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