FDA Recall Terminated

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.

Recall: Z-1681-2020 · Initiated December 30, 2019

Recall

Recall Number: Z-1681-2020
Event Number: 85314
Firm: Solta Medical Inc
FEI Number: 3004106598
Product Code: GEI
Status: Terminated
Root Cause: Process design
Initiated: December 30, 2019
Terminated: April 29, 2024
Address: 11720 N Creek Pkwy N, Ste 100, Bothell, WA, 98011-8244

Description

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.

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 [email protected] or fax at 1-800-685-6430 within 5 days. Solta Customer Service has followed up with customers via phone call and/or email.

Distribution

US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand.

Quantity

4472 units