FDAFDA · Food and drugs·Recall number Z-1186-2013
SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures
Published May 8, 2013 · Recall initiated: July 21, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Discus Dental LLC
- Distributor
- Nationwide Distribution including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, and WA.
- Lot
- Model LR2002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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