Home / Recalls / Sonendo Inc / Z-0234-2023

Z-0234-2023 Class II Ongoing

Recalled by Sonendo Inc — Laguna Hills, CA

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: 16 instruments

Product Description

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

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 Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R