CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report
Solea 0 Laser Surgical instrument for use in general recalled
Convergent Dental is recalling Solea 0 Laser Surgical instrument for use in general and plastic surgery and dermatology, distributed in Connecticut, Massachusetts, New York. The recall was initiated on 12 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0050-2014
- FDA event ID
- 66361
- Recalling firm
- Convergent Dental, Natick, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2013
- FDA classified
- 22 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 12 Sep 2013 | Recall initiated by company | |
| 22 Oct 2013 | Classified by FDA | +40 days |
| 30 Oct 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific error condition could lead to unintended laser emission during laser activation.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Where it was distributed
US distribution including states of: MA, CT, NY.
Questions about this recall
Is Solea 0 Laser Surgical instrument for use in general and plastic surgery and dermatology recalled?
Yes. Convergent Dental recalled Solea 0 Laser Surgical instrument for use in general and plastic surgery and dermatology on 12 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0050-2014.
Why was it recalled?
Specific error condition could lead to unintended laser emission during laser activation.
Which lots are affected?
Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13
Where was it sold?
US distribution including states of: MA, CT, NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Convergent Dental
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal recalled | Convergent Dental | Other | Nationwide |
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