Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 6, 2020
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.
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 incr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalled Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref … - a moderate-severity action.
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref … was recalled by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical in May 6, 2020. Reason: An issue within production process used to package trial kits let to the inclusion of the incorrect bonding …. Check the official notice for the remedy. Verify recall #Z-1824-2020 with the FDA Devices before acting.
The recall
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical issued this moderate-severity FDA Devices recall-An issue within production process used to package trial kits let to the inclusion of the incorrect bonding ….
- Moderate
- severity level
- Class II
- classification
- May 6, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1824-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1824-2020) was formally reported on May 6, 2020, with the manufacturer initiating the action on February 25, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical is listed as the recalling firm, operating out of Orange, CA. Federal records list the affected scope as 111 kits.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
111 kits
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1824-2020 |
| Date reported | May 6, 2020 |
| Date initiated | February 25, 2020 |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| Firm location | Orange, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1824-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1824-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 6, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.