Z-0324-2024Class II

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226...

Name: Z-0324-2024 Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226...
Creator: Convergent Dental
Published: 2023-09-01
License: https://open.fda.gov/license/

Convergent Dental / initiated 2023-09-01 / Open, Classified

FDA source

Convergent Dental began a recall of Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked on 2023-09-01. FDA classified it as Class II and gives the reason as "It has been found that potential unintended laser activation can occur without foot pedal depression". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0324-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-01
Posted: 2023-11-17
Recalling firm: Convergent Dental
Product: Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Product code: NVK Laser, Dental, Soft Tissue
Reason for recall: It has been found that potential unintended laser activation can occur without foot pedal depression.
FDA root cause: Under Investigation by firm
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/1/23 was sent to customers. Please discontinue use of this product until your replacement foot pedal arrives. A replacement foot pedal (part number CUS-00226 Rev Q) will be shipped to the address that we have on file for your office and should arrive no later than September 6, 2023. Your shipment tracking number is [Insert]. A return shipping label will be included in the package. Please send back your original foot pedal for inspection and monitored disposal. Connecting the replacement foot pedal will resolve this issue with no further action required. The part number and sub part number can be found at the bottom of your Solea foot pedal as shown in the attached photo. If the part number, sub-part number, and revision number do not match the recalled product, please call me directly at 617-480-3213. Convergent Dental is committed to product quality as well as patient and user safety. If you have any questions about this recall, please contact our Customer Support line at 508-500-5670. An Acknowledgement and Receipt Form is attached. Please complete the form and return it to Convergent Dental. An amended URGENT: MEDICAL DEVICE RECALL was sent to customers on 9/5/23. Protective eyewear must be worn by everyone who is in the operating environment while the laser is turned on (Armed State). Periodically inspect protective eyewear (laser safety glasses) for pitting and cracking. Please be warned that failure to follow these measures may lead to ocular damage.
Quantity in commerce: 39 units
Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.
Product codes and lots: Solea Model 3.0: UDI-DI: 00850634007018; Serial Numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0324-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0324-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17

Product code NVK

K221761Class IISoleaConvergent Dental, Inc. / cleared 2022-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)