Recall Z-1824-2020 ยท EMA Cement, Dental
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.
| Date | Feb 25, 2020 |
| Status | Terminated |
| 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 ENCLOS |
| 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. |
| FDA record | Open on fda.gov |