Recall Z-0264-2009 ยท EBF Material, Tooth Shade, Resin
Kerr Corp
PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite
| Date | Nov 25, 2008 (initiated Sep 5, 2008) |
| Status | Terminated |
| Reason | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. |
| Root cause | Component design/selection |
| Action | Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attac |
| Quantity | 22,478 packs for all affected lots |
| Distribution | Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060472 | PREMISE FLOWABLE Kerr Corporation, Apr 28, 2006 |