Events

Recall of Device Recall SL3 SOFTTISSUE Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Discus Dental LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64621
  • Event Risk Class
    Class 2
  • Event Number
    Z-1186-2013
  • Event Initiated Date
    2011-07-21
  • Event Date Posted
    2013-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116642
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • 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.

Device

Device Recall SL3 SOFTTISSUE Laser
  • Model / Serial
    Model LR2002
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • 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
  • Manufacturer
    Discus Dental LLC

Manufacturer

Discus Dental LLC
  • Manufacturer Address
    Discus Dental LLC, 8550 Higuera St, Culver City CA 90232-2522
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA