Class 2 Device Recall Solea

• Date Initiated by Firm: September 01, 2023
• Date Posted: November 17, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0324-2024
• Recall Event ID: 93203
• 510(K)Number: K221761
• Product Classification: Laser, dental, soft tissue - Product Code NVK
• Product: Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
• 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
• Recalling Firm/ Manufacturer: Convergent Dental; 140 Kendrick St Bldg C3; Needham MA 02494-2739
• For Additional Information Contact: Customer Support; 508-500-5670
• Manufacturer Reason for Recall: It has been found that potential unintended laser activation can occur without foot pedal depression.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NVK