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U.S. Department of Health and Human Services

Class 2 Device Recall Sonendo GentleWave System

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  Class 2 Device Recall Sonendo GentleWave System see related information
Date Initiated by Firm October 14, 2022
Date Posted November 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0233-2023
Recall Event ID 91045
510(K)Number K190359  
Product Classification Scaler, ultrasonic - Product Code ELC
Product GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Code Information GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R
Recalling Firm/
Sonendo Inc
26051 Merit Cir Ste 104
Laguna Hills CA 92653-7008
For Additional Information Contact Steven L. Ziemba
Manufacturer Reason
for Recall
Procedure Instruments with erroneous unit carton labels.
FDA Determined
Cause 2
Under Investigation by firm
Action On 10/14/2022, the firm sent an "URGENT PRODUCT ADVISORY NOTICE" Letter via FedEx to customers informing them that there are error in the external labeling on the product carton. Information missing includes: a) The GentleWave brand identification; b) The Sonendo brand identification; c) Information such as: "Manufactured by:" and various ISO informational labeling symbols Customers are instructed: -Complete and return (fax or email) the Customer Acknowledgement Letter. -No other action are required. The product and the labeling on the product pouches inside the cartons is correct and unaffected by this error. The labeling has sufficient information to ensure that all customer can correctly identify different Procedure Instruments prior to use. This Notice is intended to reduce any possible confusion to the customer due to the labeling error. For questions, contact Sonendo Customer Support between 7:00 a.m. to 4:00 p.m. (PST) at 1-844-468-5928 or via email to complaints@sonendo.com
Quantity in Commerce 15 instruments
Distribution Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = ELC and Original Applicant = Sonendo, Inc.