Z-1824-2020 Class II Terminated
FDA device recall Z-1824-2020 was initiated by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical on February 25, 2020 and is designated Class II. 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 fa… The recall status is terminated (terminated May 19, 2021). Affected quantity: 111 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- February 25, 2020
- Termination Date
- May 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111 kits
Product Description
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.
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.
Distribution Pattern
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.
Code Information
Lot Numbers: 7402423, 7290257, 7451039