FDA Medical Device Recalls (openFDA)
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical: 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.
- Recall number
- Z-1824-2020
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- 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.
- Status
- Terminated
- Initiated
- 2020-02-25
- Posted
- not on file
- Terminated
- 2021-05-19
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 7402423, 7290257, 7451039
- 510(k) numbers
- ["K001899","K191548"]
- PMA numbers
- not on file
- Product code
- EMA
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28