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Recall Observatory FDA recall evidence

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

February 12, 2016

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
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

    reason.manufacturing_process_control · v1.0.0

    production batch U30755 of Helioseal Clear. This failure