Class 2 Device Recall THERMAGE CPT SYSTEM

• Date Initiated by Firm: December 30, 2019
• Create Date: April 07, 2020
• Recall Status: Terminated on April 29, 2024
• Recall Number: Z-1681-2020
• Recall Event ID: 85314
• 510(K)Number: K132431
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• 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.
• 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
• Recalling Firm/ Manufacturer: Solta Medical Inc; 11720 N Creek Pkwy N Ste 100; Bothell WA 98011-8244
• For Additional Information Contact: Solta Medical; 1877-782-2286 Ext. 1
• Manufacturer 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.
• FDA Determined Cause: Process design
• Action: On 12/30/2019, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" to customers via registered mail to inform them that they have become aware that there is a potential problem related to their device that may result in patient burns. This recall affects 20 lots manufactured and distributed between 08/14/2019 and 12/12/2019. The firm is instructing the customers to: 1. Review their inventory for all devices impacted by this voluntary recall and remove them from the inventory. 2. The manufacturer/ recalling firm is asking their customers to contact Customer Service at 1-877-782-2286 option 1 to arrange the return of the impacted devices in the inventory. 3. In addition, the firm is requesting the customers to complete the enclosed Product Recall Acknowledgement Form and return it to the manufacturer via email at orders@solta.com or fax at 1-800-685-6430 within 5 days. Solta Customer Service has followed up with customers via phone call and/or email.
• Quantity in Commerce: 4472 units
• Distribution: US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI and Original Applicant = SOLTA MEDICAL, INC.