Recall Z-0376-2014 ยท MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Ivoclar Vivadent, Inc.
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
| Date | Nov 21, 2013 (initiated Sep 23, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | 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 Me |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093744 | EXCITE F AND EXCITE DSC Ivoclar Vivadent, Inc., Mar 10, 2010 |