Ivoclar Vivadent Recalls ExciTE F DSC Dental Adhesive Due to Discoloration
Ivoclar Vivadent is recalling ExciTE F DSC Dental Adhesive because it produces blue-green discoloration when used with cements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to cosmetic discoloration with no reported injuries or health risks, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling a specific lot of ExciTE F DSC Soft touch Single Dose, Dual-curing Regular dental adhesive. The recall was initiated because the product was found to produce a blue-green discoloration when used in combination with cements.
The affected product is identified by Product Code 630378AN, Lot Number R59595, and an expiration date of January 3, 2015. The recall involves 63 refill packs, with each refill containing 50 single-use applications. The product was distributed in the United States, including the states of Pennsylvania, Washington, Wisconsin, New York, Louisiana, Texas, New Jersey, California, Oregon, Iowa, South Carolina, Indiana, Illinois, and Arizona.
This is a Class II recall. Consumers and dental professionals should check their inventory for the specific lot number and product code listed above. If the product matches the recalled lot, it should be removed from use and returned to the supplier or manufacturer according to their instructions.
The recalled product
- Product
- ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
- Manufacturer
- Ivoclar Vivadent, Inc.
- Category
- Medical Device — Dental Adhesive
- Hazard
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 (3)
- Product Code 630378AN
- Lot Number: R59595
- Expiration date of 3 January 2015
Distribution
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