Recall Z-0916-2010 ยท EBF Material, Tooth Shade, Resin
Sybron Dental Specialties
Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
| Date | Mar 2, 2010 (initiated Feb 23, 2009) |
| Status | Terminated |
| Reason | Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card. |
| Root cause | Labeling mix-ups |
| Action | Kerr Corporation issued a letter dated February 23, 2009. Users were informed of the affected product and instructed on proper return. For further information, contact Kerr Customer Care at 1-800-537-7123. |
| Quantity | 442 |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082671 | HERCULITE ULTRA Sybron Dental Specialties, Dec 11, 2008 |