SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a
FDA device recall Z-1186-2013 · posted 2013-04-29 · Terminated
Recall details
- Recalling firm
- Discus Dental LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 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.
- Date initiated
- 2011-07-21
- Date posted
- 2013-04-29
- Date terminated
- 2013-04-29
- Location
- Culver City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SL3 (K102639) | Discus Dental, LLC | 2010-12-01 |