Skip to content
Recall Observatory FDA recall evidence

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.

Z-1824-2020

February 25, 2020

Class II

Product summary

Firm
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Event
Event 85284
Status
Terminated
Classification
Class II
Quantity
111 kits
Official record key
device-enforcement:Z-1824-2020

Official wording

Reason: 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.

Code information: Lot Numbers: 7402423, 7290257, 7451039

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.