Convergent Dental: Medical Device Recall in 2023 - (Recall #: Z-0324-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 1, 2023

Date Posted: November 29, 2023

Recall Number: Z-0324-2024

Event ID: 93203

Reason for Recall:

It has been found that potential unintended laser activation can occur without foot pedal depression.

Status: Ongoing

Product Quantity: 39 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated