Orange, CA, United States
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls
2 recalls recorded since 2018, most recently on 25 February 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 February 2020
- Terminated
- 19 May 2021
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1824-2020
- 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 vene
Terminated Class II Medical devices
- Recall started
- 13 July 2018
- Terminated
- 5 May 2021
- Reason
- Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
- Distribution
- AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1721-2019
- Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.