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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Solta Medical Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Distribution:
Distributed in: US, AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX, UT, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1681-2020
Related Recalls
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.