Drug recall
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226…
FDA recall event 93203 · Class II · Convergent Dental
Key facts
| Event ID | 93203 |
|---|---|
| Recall numbers | Z-0324-2024 |
| Recalling firm | Convergent Dental |
| Product type | Devices |
| Products | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been found that potential unintended laser activation can occur without foot pedal depression. |
| Initiation date | Sep 1, 2023 |
| Report date | Nov 29, 2023 |
| City | Needham |
| State | MA |
| Country | United States |
| FEI number | 3010175098 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: