Recall Z-1824-2020— Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Class II · Terminated
Class II FDA medical device recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, initiated 2020-02-25, terminated 2021-05-19. It names 2 FDA 510(k) clearances: K191548, K001899. 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: 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..
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-25
- Terminated
- 2021-05-19
- Firm location
- Orange, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.