Summary
The FDA issued a Class II for GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 by Sonendo Inc. Reason: Procedure Instruments with erroneous unit carton labels..
Details
Source
Device Recall
External ID
Z-0233-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
Product Description
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Lot/Code Info: GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R
Quantity Affected: 15 instruments
Reason for Recall
Procedure Instruments with erroneous unit carton labels.
Distribution
Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-14
Company
Laguna Hills, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sonendo Inc has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sonendo Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sonendo Inc have FDA actions?
Sonendo Inc has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0233-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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