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U.S. Department of Health and Human Services

Class 2 Device Recall SL3 SOFTTISSUE Laser

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 Class 2 Recall
SL3 SOFTTISSUE Laser
see related information
Date Posted April 29, 2013
Recall Status1 Terminated on April 29, 2013
Recall Number Z-1186-2013
Recall Event ID 64621
Premarket Notification
510(K) Number
K102639 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product 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
Code Information Model LR2002
Recalling Firm/
Manufacturer
Discus Dental LLC
8550 Higuera St
Culver City, California 90232-2522
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = DISCUS DENTAL, LLC
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