Recall Z-1186-2013 ยท GEX Powered Laser Surgical Instrument
Discus Dental LLC
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
| Date | Apr 29, 2013 (initiated Jul 21, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 150 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102639 | SL3 Discus Dental, LLC, Dec 1, 2010 |