BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-1186-2013 · Reported May 8, 2013

    Enforcement

    Recall Number
    Z-1186-2013
    Event ID
    64621
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Discus Dental LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2013
    Initiation Date
    July 21, 2011
    Classification Date
    April 29, 2013
    Termination Date
    April 29, 2013
    Address
    8550 Higuera St, Culver City, CA, 90232-2522, United States

    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

    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.

    Code Info

    Model LR2002

    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.

    Quantity

    150 units