SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City...
FDA Recall #Z-1186-2013 — Class II — July 21, 2011
Product Description
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
Reason for Recall
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.
Recalling Firm
Discus Dental LLC — Culver City, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
150 units
Distribution
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.
Code Information
Model LR2002
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated