Nexus Universal with OptiBond Universal — Class II medical device recall Z-1824-2020
Terminated recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, reported 2020-05-06, distributed nationwide. An issue within production process used to package trial kits let to the inclusion of the incorrect bonding ag
| Recall number | Z-1824-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, Orange, CA, United States |
| Recall initiated | 2020-02-25 |
| Classified | 2020-04-29 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2021-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 111 kits |
| Lot numbers | 7290257, 7402423, 7451039 |
| Model numbers | 36990 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1824-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.