Sonendo Inc Recall 91045
Description: GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Sonendo Inc Recall 91045 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0233-2023 |
| Event ID | 91045 |
| Event Description | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 |
| Product Type | Devices |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada. |
| Quantity | 15 instruments |
| Recall Reason | Procedure Instruments with erroneous unit carton labels. |
| Device Classification | 20221123 |
| Device Code Info | GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R |
| Center Classification Date | 20221114 |
| Recall Initiation Date | 20221014 |
| Recalling Firm | Sonendo Inc |
| Initial Notification | Letter |
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