Recall Z-0716-2011 ยท EBF Material, Tooth Shade, Resin
Patterson Dental Supply, Inc.
SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Li
| Date | Dec 17, 2010 (initiated Oct 15, 2010) |
| Status | Terminated |
| Reason | Patterson Dental is conducting a recall because they have been advised by the manufacturer of Revolution Formula 2 (Kerr Corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by Kerr and, thus, not authentic product. |
| Root cause | Other |
| Action | Consignees were sent a Patterson Dental "Urgent Device Recall" letter dated October 15, 2010. The letter was addressed to "Valued Customer". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com. |
| Quantity | 3,204 packages |
| Distribution | Nationwide Distribution -- Including DC except VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013647 | REVOLUTION FORMULA 2 Sybron Dental Specialties, Inc., Jan 16, 2002 |