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.
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.
조치
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.
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.
제품 설명
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