SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Co
FDA device recall Z-0716-2011 · posted 2010-12-17 · Terminated
Recall details
- Recalling firm
- Patterson Dental Supply, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- EBF
- Quantity affected
- 3,204 packages
- Distribution
- Nationwide Distribution -- Including DC except VT.
- Date initiated
- 2010-10-15
- Date posted
- 2010-12-17
- Date terminated
- 2012-09-11
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION FORMULA 2 (K013647) | Sybron Dental Specialties, Inc. | 2002-01-16 |