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U.S. Department of Health and Human Services

Class 2 Device Recall Helioseal Clear

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  Class 2 Device Recall Helioseal Clear see related information
Date Initiated by Firm February 12, 2016
Date Posted February 29, 2016
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-1026-2016
Recall Event ID 73308
510(K)Number K813015  
Product Classification Sealant, pit and fissure, and conditioner - Product Code EBC
Product Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Code Information REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020) 
Recalling Firm/
Ivoclar Vivadent, Inc.
175 Pineview Dr
Buffalo NY 14228-2231
For Additional Information Contact Donna Marie Hartnett, Esq.
Manufacturer Reason
for Recall
Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Ivoclar Vivadent sent an Urgent Medical Device Recall letter dated February 11, 2016, to all consignees via Certified Mail, Return Receipt Requested. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete, sign and return the attached acknowledgement form and return it to Ivoclar Vivadent via fax (716) 691-2294 or e-mail at recall.us@ivoclarvivadent.com. Contact Ivoclar Vivadent Customer Service at 1-800-533-6825 as soon as possible between the hours of 8:00 am and 6:00 pm EST Monday through Friday and a representative will arrange to pick up your affected materials for return and credit. Please notify your customers of this issue and return the product to us. For questions, please contact Ivoclar Vivadent Customer Service at 800-533-6825.
Quantity in Commerce Domestic: 406 units
Distribution Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
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 = EBC and Original Applicant = VIVADENT (USA), INC.