Recall Z-1026-2016 ยท EBC Sealant, Pit And Fissure, And Conditioner
Ivoclar Vivadent, Inc.
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
| Date | Feb 29, 2016 (initiated Feb 12, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 representa |
| Quantity | Domestic: 406 units |
| Distribution | Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K813015 | HELIOSEAL Vivadent (Usa), Inc., Dec 2, 1981 |