Recall Z-0213-2016 ยท EBC Sealant, Pit And Fissure, And Conditioner
Ivoclar A. G.
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and fo
| Date | Nov 4, 2015 (initiated Oct 7, 2015) |
| Status | Terminated |
| Reason | A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material. |
| Root cause | Under Investigation by firm |
| Action | Ivoclar Vivadent sent an Urgent Medical Device Recall Letter dated October 7, 2015, with Response Forms via Certified Mail, Return Receipt Requested. Dealers were also contacted via telephone/e-mail and informed to expect the letter. Dealers are requested to check their stock and return any affected material for credit, plus notify their customers of the recall. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825. |
| Quantity | Domestic: 337 units |
| Distribution | Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932078 | HELIOSEAL F Ivoclar North America, Inc., Sep 15, 1993 |