The Recall Desk
HighFDA (Devices)·Z-1681-2020·Announced 2020-04-15

Solta Medical Recalls Thermage Face Tips Due to Sparking and Burn Risk

Solta Medical is recalling Thermage Face Tip 3.0 units because sparking during use could cause skin burns.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential skin burns) where specific injury counts are not reported, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Solta Medical Inc. is recalling 4,472 units of Thermage Face Tip 3.0, a medical device used in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The recall was initiated due to complaints that the tips of the electrosurgical device spark during radiofrequency (RF) surgical procedures.

The use of the affected treatment tips could contribute to potential skin burns. The affected units are distributed in the United States (AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX, UT, and WA) and internationally in Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand.

Healthcare providers and consumers should stop using the affected Thermage Face Tip 3.0 units immediately. Solta Medical Inc. is the recalling firm responsible for managing the recall.

The recalled product

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.
Manufacturer
Solta Medical Inc
Category
Medical Device — Electrosurgical Device
Hazard
Affected units
4,472

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 12 states:

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