Kerr Recalls NX3 Try-In Gel Due to Material Mismatch
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel because some syringes contain a different material than the labeled shade.
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: This is a voluntary precautionary recall involving a labeling/material mismatch without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, a tooth shade resin material. The recall affects 197 units distributed worldwide, including in the United States, Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil, and Saudi Arabia.
The recall is being issued because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringes does not match the shade of the cement as it is labeled.
The affected product is identified by Part Number 33660, Syringe Lot Number 4580333, and Autobag Lot Number 4584609. Consumers and healthcare professionals should check their inventory for these specific lot numbers and stop using the product if it matches the recall description.
The recalled product
- Product
- NX3 Try-In Gel. The product is used as a tooth shade resin material.
- Hazard
- Affected units
- 197
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 (1)
- Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
Distribution
Distributed nationwide across the United States.
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