ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
FDA device recall Z-0376-2014 · posted 2013-11-21 · Terminated
Recall details
- Recalling firm
- Ivoclar Vivadent, Inc.
- Reason for recall
- Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.
- Action taken
- The firm, Ivoclar Vivadent, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MZW
- Quantity affected
- 63 refill packs (50 single use applications per refill)
- Distribution
- US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
- Date initiated
- 2013-09-23
- Date posted
- 2013-11-21
- Date terminated
- 2016-05-27
- Location
- Buffalo, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXCITE F AND EXCITE DSC (K093744) | Ivoclar Vivadent, Inc. | 2010-03-10 |