GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Reported: November 23, 2022 Initiated: October 14, 2022 #Z-0234-2023
Product Description
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Reason for Recall
Procedure Instruments with erroneous unit carton labels.
Details
- Recalling Firm
- Sonendo Inc
- Units Affected
- 16 instruments
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
- Location
- Laguna Hills, CA
Frequently Asked Questions
What product was recalled? ▼
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01. Recalled by Sonendo Inc. Units affected: 16 instruments.
Why was this product recalled? ▼
Procedure Instruments with erroneous unit carton labels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0234-2023.
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