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.
Reported: May 6, 2020 Initiated: February 25, 2020 #Z-1824-2020
Product Description
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.
Details
- Recalling Firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Units Affected
- 111 kits
- 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.
- Location
- Orange, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical. Units affected: 111 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1824-2020.
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