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
FDA Recall Z-1186-2013 · Posted 2013-04-29
Recalling FirmDiscus Dental LLC
Recall StatusTerminated
Product CodeGEX
Date Initiated2011-07-21
Date Terminated2013-04-29
Product Quantity150 units
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.