Kerr Maxcem Elite Resin Cement Recalled for Premature Polymerization
Kerr Corporation is recalling Kerr Maxcem Elite resin cement kits and syringes because raw material causes the product to set prematurely, potentially preventing proper restoration placement.
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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (premature setting) that may lead to improper restoration placement, fitting the criteria for a moderate severity voluntary recall without reported harm.
Plain-English summary
Kerr Corporation is recalling Kerr Maxcem Elite, a self-etch/self-adhesive resin cement used for cementing indirect restorations. The recall involves 40,819 kit and syringe units, including Intro Kits, Bulk Kits, Standard Kits, Value Kits, Mini Kits, and various refill and filled syringe configurations.
The recall was initiated because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. This defect can make the product difficult to extrude or result in a shorter work-time, as the material may set before the dentist can place the restoration on the tooth or core build-up. Consequently, the restoration may not be seated properly.
The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries. Consumers and dental professionals should check their inventory against the specific lot numbers and part numbers listed in the official recall notice. If the product is found, it should be stopped from use and returned to the supplier or manufacturer for replacement or refund.
The recalled product
- Product
- Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
- Affected units
- 40,819
Distribution
Distributed nationwide across the United States.
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