Reported May 6, 2020 · Terminated
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The…
Kerr/Pentron, dba Kerr Corporation and Pentron Clinical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical · 1717 W Collins Ave · Orange, CA · 92867-5422
Is this the product you have?
- Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 -
- Product UsageThe 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
- Lot codes and dates
- Lot Numbers
740242372902577451039
- Lot Numbers
- Amount recalled
- 111 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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