Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1824-2020 — 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 t

U.S. FDA — Device Enforcement · United States · 2020-02-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1824-2020
Date of alert: 2020-02-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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