Thermage Face Tip 3.0 recall
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…
Why was Thermage Face Tip 3.0 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Solta Medical Inc
- Quantity
- 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.
- Recall date
- April 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)