Recall Z-0324-2024— Convergent Dental

Name: FDA recall Z-0324-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-01

Class II · Ongoing

Class II FDA medical device recall by Convergent Dental, initiated 2023-09-01. It names one FDA 510(k) clearance: K221761. Product: Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked. Reason: It has been found that potential unintended laser activation can occur without foot pedal depression..

Recalling firm: Convergent Dental
Classification: Class II
Status: Ongoing
Initiated: 2023-09-01
Firm location: Needham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K221761 — SoleaConvergent Dental, Inc.·cleared 2022-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.