Recall Z-1076-2013 ยท MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
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.
| Date | Apr 10, 2013 (initiated Feb 22, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Kerr Corporation/Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 22, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers are instructed to determine if you have any of the affected products in your inventory; If you have the affected lots, please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number for quick return; complete and return the Maxcem Elite Acknowledgement and Recall Return Form via fax to 714-288-4609 regardless of whether you have any product in your inventor |
| Quantity | 40,819 kit and syringe units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073209 | MAXCEM 2 Kerr Corporation, Jan 29, 2008 |