Device recall
Z-1681-2020: Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF…
FDA device recall · Class II · Solta Medical Inc
Key facts
| Recall number (Z-number) | Z-1681-2020 |
|---|---|
| Recall event | 85314 |
| 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. |
| Product code | GEI |
| Recalling firm | Solta Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2024 |
| 510(k) numbers | K132431 |
| FEI number | 3004106598 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database