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Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The i
Recalled May 6, 2020 · FDA recall Z-1824-2020 · Kerr/Pentron,
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. · FDA Class II
Units
111 kits
Sold at
Worldwide distribution - US Nationwide distribution in the states of NV, TN, NY, WA, WI, GA, PA, TX, IN, FL, IL, IA, MD, CA, LA, , MI, AZ, NC, KY, SC and the country of Netherlands.
Description
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.
Product
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 to implant abutments.
Manufacturer(s)
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →