Z-0233-2023 Class II Ongoing
FDA device recall Z-0233-2023 was initiated by Sonendo Inc on October 14, 2022 and is designated Class II. Reason for recall: Procedure Instruments with erroneous unit carton labels. The recall status is ongoing. Affected quantity: 15 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2022
- Initiation Date
- October 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 instruments
Product Description
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Reason for Recall
Procedure Instruments with erroneous unit carton labels.
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Code Information
GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R