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

Recalled November 23, 2022 · FDA recall Z-0234-2023 · Sonendo

Hazard

Procedure Instruments with erroneous unit carton labels. · FDA Class II

Units

16 instruments

Sold at

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

Description

Procedure Instruments with erroneous unit carton labels.

Product

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

Manufacturer(s)

Sonendo Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →