Recall Z-0074-2010 ยท EMA Cement, Dental
Kerr Corp
Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.
| Date | Oct 23, 2009 (initiated Sep 9, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable. |
| Root cause | Nonconforming Material/Component |
| Action | Kerr Corporation issued an "Urgent Medical Device Recall" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. |
| Quantity | 13,518 units |
| Distribution | Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982590 | TEMPBOND CLEAR-2 Sybron Dental Specialties, Inc., Oct 8, 1998 |