FDA Device recall Z-1681-2020

Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377

FDA Device
Class II
terminated
Published 2020-04-15

On 2020-04-15 the FDA classified a Class II recall of Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377 by Solta Medical, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1681-2020
Classification	Class II
Status	terminated
Initiated	2019-12-30
Published	2020-04-15
Last updated	2026-09-13 11:55 UTC
Company	Solta Medical
Distribution	AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX, UT, WA

Product

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.

Reason

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.

Identifiers

code_info	Model Number /Lot Numbers: TTNS3.00C3-400: DOM 120519 011, DOM 120419 014, DOM 120219 008, DOM 112619 006, DOM 112019… Model Number /Lot Numbers: TTNS3.00C3-400: DOM 120519 011, DOM 120419 014, DOM 120219 008, DOM 112619 006, DOM 112019 010, DOM 111519 004, DOM 100819 005, DOM 100119 005, DOM 082319 003, DOM 081919 007, DOM 081419 004; TTNS3.00C3-600: DOM 120419 018, DOM 112019 009, DOM 110119 010, DOM 092319 005, DOM 082219 015, DOM 082119 006; TTNS3.00C3-900: DOM 111819 005, DOM 092319 006 , DOM 081419 005 Lot number/Number of Units Affected 120219-008/180, 112619-006/225, 112019-010/225, 112019-009/420, 111519-004/220, 110119-010/398, 100819-005/405, 092319-006/23, 092319-005/342, 082319-003/525, 082219-015/504, 082119-006/252, 081419-007/135, 081419-005/126, 081419-004/492 REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391

code_info

Model Number /Lot Numbers: TTNS3.00C3-400: DOM 120519 011, DOM 120419 014, DOM 120219 008, DOM 112619 006, DOM 112019…

Model Number /Lot Numbers: TTNS3.00C3-400: DOM 120519 011, DOM 120419 014, DOM 120219 008, DOM 112619 006, DOM 112019 010, DOM 111519 004, DOM 100819 005, DOM 100119 005, DOM 082319 003, DOM 081919 007, DOM 081419 004; TTNS3.00C3-600: DOM 120419 018, DOM 112019 009, DOM 110119 010, DOM 092319 005, DOM 082219 015, DOM 082119 006; TTNS3.00C3-900: DOM 111819 005, DOM 092319 006 , DOM 081419 005 Lot number/Number of Units Affected 120219-008/180, 112619-006/225, 112019-010/225, 112019-009/420, 111519-004/220, 110119-010/398, 100819-005/405, 092319-006/23, 092319-005/342, 082319-003/525, 082219-015/504, 082119-006/252, 081419-007/135, 081419-005/126, 081419-004/492 REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1681-2020%22

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