Class 2 Device Recall Nexus Universal with OptiBond Universal Trial Kit

• Date Initiated by Firm: February 25, 2020
• Create Date: April 29, 2020
• Recall Status: Terminated on May 19, 2021
• Recall Number: Z-1824-2020
• Recall Event ID: 85284
• 510(K)Number: K001899 K191548
• Product Classification: Cement, dental - Product Code EMA
• 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.
• Code Information: Lot Numbers: 7402423, 7290257, 7451039
• Recalling Firm/ Manufacturer: Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical; 1717 W Collins Ave; Orange CA 92867-5422
• For Additional Information Contact: Paulo Calle; 714-516-7400
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EMA; 510(K)s with Product Code = EMA