Device 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
Z-1026-2016
Product summary
- Event
- Event 73308
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 406 units
- Official record key
device-enforcement:Z-1026-2016
Official wording
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.
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.
Derived failure modes
-
Manufacturing or process control
production batch U30755 of Helioseal Clear. This failure