FDA recall Z-0234-2023

Sonendo Inc · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2022-10-14
Report date
2022-11-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Laguna Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2023