Z-1824-2020Class II

Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 -

Name: Z-1824-2020 Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 -
Creator: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Published: 2020-02-25
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2020-02-25 / Terminated / root cause: manufacturing process

FDA source

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical began a recall of 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... on 2020-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1824-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-25
Posted: 2020-04-29
Terminated: 2021-05-19
Recalling firm: Sybron Dental Specialties, Inc.
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.
Product code: EMA Cement, Dental
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 25, 2020, Kerr sent a "Urgent: Medical Device Recall" letter via. USPS to affected consignees informing them about the recall associated with the Nexus Universal Trial Kit (#36990). In addition to informing consignees about the recall, the notification asked consignees to take the following actions: 1. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement. 2. KERR CORPORATION KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND EMAILING BACK THE ENCLOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS FIELD CORRECTION LETTER, REGARDLESS OF WHETHER YOU HAVE ANY PRODUCT IN YOUR INVENTORY 3. If you are an authorized Kerr Corporation distributor, we request that you identify those customers that may have been shipped the affected product and contact these customers to inform them of the issue.
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 7402423, 7290257, 7451039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1824-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code EMA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)