CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report
Nexus Universal with OptiBond Universal recalled by Kerr/Pentron
Kerr/Pentron is recalling Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, distributed nationwide in the US. The recall was initiated on 25 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1824-2020
- FDA event ID
- 85284
- Recalling firm
- Kerr/Pentron, Orange, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2020
- FDA classified
- 29 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Dental Devices
Timeline
| 25 Feb 2020 | Recall initiated by company | |
| 29 Apr 2020 | Classified by FDA | +64 days |
| 6 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKentuckyLouisianaMarylandMichiganNorth CarolinaNevadaNew YorkPennsylvaniaSouth CarolinaTennesseeTexasWashingtonWisconsin
Questions about this recall
Is Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit recalled?
Yes. Kerr/Pentron recalled Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit on 25 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1824-2020.
Why was it 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 lots are affected?
Lot Numbers: 7402423, 7290257, 7451039
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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