Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
FDA device recall Z-0916-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- EBF
- Quantity affected
- 442
- Distribution
- Nationwide distribution
- Date initiated
- 2009-02-23
- Date posted
- 2010-03-02
- Date terminated
- 2012-03-19
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HERCULITE ULTRA (K082671) | Sybron Dental Specialties | 2008-12-11 |