Class 2 Device Recall Excite F. DSC

• Date Initiated by Firm: September 23, 2013
• Date Posted: November 21, 2013
• Recall Status: Terminated on May 27, 2016
• Recall Number: Z-0376-2014
• Recall Event ID: 66359
• 510(K)Number: K093744
• Product Classification: Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
• Product: ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
• Code Information: Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015
• FEI Number: 1316092
• Recalling Firm/ Manufacturer: Ivoclar Vivadent, Inc.; 175 Pineview Dr; Buffalo NY 14228-2231
• For Additional Information Contact: 716-691-0010
• Manufacturer 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.
• FDA Determined 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 Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MZW