Product Safety Recalls

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Sonendo Inc Recall 91045

Description: GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

Sonendo Inc Recall 91045 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0233-2023
Event ID91045
Event DescriptionGentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Product TypeDevices
DistributionWorldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Quantity15 instruments
Recall ReasonProcedure Instruments with erroneous unit carton labels.
Device Classification20221123
Device Code InfoGentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R
Center Classification Date20221114
Recall Initiation Date20221014
Recalling FirmSonendo Inc
Initial Notification Letter
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