Ivoclar Vivadent Recalls Helioseal Clear Pit and Fissure Sealant
Ivoclar Vivadent is recalling Helioseal Clear dental sealant because a production error may prevent the material from curing properly under specific lights.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional failure of a medical device that could lead to incomplete curing, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling Helioseal Clear Refill and Assortment products, which are used as pit and fissure sealants in dental care. The recall involves specific product codes 558521AN and 558520AN. The company has identified 406 units of the affected product in domestic distribution.
The recall was initiated after complaints indicated that the material failed to polymerize, or harden, when exposed to a curing light. An investigation determined that a wrong photo-initiator was used in the production of the affected batches. This error can lead to incomplete curing of the sealant if mono-wave LED curing lights are used.
The affected products were distributed nationwide, including in New York, Pennsylvania, Florida, Indiana, Iowa, Texas, and California. Dental professionals and consumers should stop using the affected lots and contact Ivoclar Vivadent for instructions on how to return the product.
The recalled product
- 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
- Ivoclar Vivadent, Inc.
- Affected units
- 406
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
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