FDA recall Z-1824-2020

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical · Class II · device

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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2020-02-25
Report date
2020-05-06
Termination date
2021-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Orange, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1824-2020