Kerr/Pentron, Recalls
4 recalls on record · April 17, 2013 to May 6, 2020 · Medical Devices
Recalls by year
13
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 6, 2020Medical DevicesFDA
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The i
Hazard: 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.
June 12, 2019Medical DevicesFDA
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Hazard: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
September 25, 2013Medical DevicesFDA
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls NX3 Try-In Gel. The product is used as a tooth shade resin material.
Hazard: Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.
April 17, 2013Medical DevicesFDA
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical recalls Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementati
Hazard: Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.