Device recall
Z-0324-2024: Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly…
FDA device recall · Class II · Convergent Dental
Key facts
| Recall number (Z-number) | Z-0324-2024 |
|---|---|
| Recall event | 93203 |
| Product | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked |
| Product code | NVK |
| Recalling firm | Convergent Dental |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K221761 |
| FEI number | 3010175098 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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