Z-1681-2020 Class II Terminated
FDA device recall Z-1681-2020 was initiated by Solta Medical Inc on December 30, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 29, 2024). Affected quantity: 4472 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- December 30, 2019
- Termination Date
- April 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4472 units
Product 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.
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.
Distribution Pattern
US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand.
Code Information
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