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…

Recall date

February 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1026-2016

FDA classification

Class II

Brand / firm

Ivoclar Vivadent, Inc.

Sold / distributed

Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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