BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0234-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0234-2023
    Event ID
    91045
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sonendo Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    October 14, 2022
    Classification Date
    November 14, 2022
    Address
    26051 Merit Cir Ste 104, N/A, Laguna Hills, CA, 92653-7008, United States

    Description

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

    Reason

    Procedure Instruments with erroneous unit carton labels.

    Code Info

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

    Distribution

    Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

    Quantity

    16 instruments