BEUDAMED
    FDA Recall 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 · Initiated July 21, 2011

    Recall

    Recall Number
    Z-1186-2013
    Event Number
    64621
    Firm
    Discus Dental LLC
    FEI Number
    3002751089
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 21, 2011
    Posted
    April 29, 2013
    Terminated
    April 29, 2013
    Address
    8550 Higuera St, Culver City, CA, 90232-2522

    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.

    Action

    DISCUS Dental, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 21, 2011. The letter described the product, problem and action to be taken. Customers were instructed tocontact Discus Dental at 1-888-427-9279 for a no-cost replacement. For questions regarding this recall call 310-845-8200.

    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