Ivoclar Vivadent, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1026-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 12, 2016

Date Posted: March 9, 2016

Recall Number: Z-1026-2016

Event ID: 73308

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.

Status: Terminated

Product Quantity: Domestic: 406 units

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated