Kerr Nexus Universal Trial Kits Recalled for Incorrect Bonding Agent
Kerr/Pentron is recalling 111 trial kits of Nexus Universal with OptiBond Universal due to a packaging error that included the incorrect bonding agent, potentially increasing the risk of bond failures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, is recalling 111 trial kits of Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Ref # 36990. The recall is due to a production process issue that resulted in the inclusion of the incorrect bonding agent for the kit.
The affected products were distributed worldwide and nationwide in the United States, specifically in the states of NV, TN, NY, WA, WI, GA, PA, TX, IN, FL, IL, IA, MD, CA, LA, MI, AZ, NC, and KY, as well as in the Netherlands. The specific lot numbers involved are 7402423, 7290257, and 7451039.
Use of the incorrect bonding agent may lead to an increased risk of bond failures. The intended use of this device is for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and crown restorations to implant abutments. Healthcare professionals should check their inventory for these specific lot numbers and stop using the affected kits.
The recalled product
- 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
- Hazard
- Affected units
- 111
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: 7402423
- 7290257
- 7451039
Distribution
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