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Ivoclar Vivadent, Inc. recalls Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Pr
Recalled March 9, 2016 · FDA recall Z-1026-2016 · Ivoclar Vivadent
Hazard
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 Class II
Units
Domestic: 406 units
Sold at
Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
Description
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.
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
Manufacturer(s)
Ivoclar Vivadent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →