Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kerr Maxcem Elite Recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical Due to Kerr Corporation is initiating this recall because raw...

Date: February 22, 2013
Company: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical directly.

Affected Products

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.

Quantity: 40,819 kit and syringe units

Why Was This Recalled?

Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical has 4 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report