Reported Apr 15, 2020 · Terminated
Thermage Face Tip 3.0, REF/UDI
Solta Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Solta Medical Inc · 11720 N Creek Pkwy N Ste 100 · Bothell, WA · 98011-8244
Is this the product you have?
Thermage Face Tip 3.0, REF/UDI
4 of 4 products
| Model / number | Product as published |
|---|---|
| — | TTNS3,00C3-400/UDI (01)000850608002377 |
TTNS3.00C3-600/UDI | (01)000850608002384 |
TTNS3.00C3-900 | — |
| — | UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published — 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 TTNS3.00C3-600/UDI(01)000850608002384 TTNS3.00C3-900UDI (01)000850608002391 - Amount recalled
- 4472 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Solta Medical Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.