Z-1186-2013 Class II Terminated
FDA device recall Z-1186-2013 was initiated by Discus Dental LLC on Jul 21, 2011 and is designated Class II. 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. The recall status is terminated (terminated Apr 29, 2013). Affected quantity: 150 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2013
- Initiation Date
- Jul 21, 2011
- Termination Date
- Apr 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units
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.
Distribution Pattern
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