Recall Z-1076-2013— Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Class II · Terminated
Class II FDA medical device recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, initiated 2013-02-22, terminated 2014-01-22. It names one FDA 510(k) clearance: K073209. Product: Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.. Reason: 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..
- Recalling firm
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-22
- Terminated
- 2014-01-22
- Firm location
- Orange, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.