Needham, MA, United States
Convergent Dental recalls
1 recall recorded since 2018, most recently on 1 September 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 September 2023
- Reason
- It has been found that potential unintended laser activation can occur without foot pedal depression.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0324-2024
- Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.