FDAFebruary 25, 2020device

Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.

What to do

FDA enforcement status: Terminated

Brands named

kerr pentron dba kerr corporation and pentron clinicalkerrkerr pentron

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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