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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64621
Product Type Devices
Status Terminated
Recalling Firm Discus Dental LLC
City Culver City
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-21
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Model LR2002 Class II 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. 150 units Z-1186-2013