Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (co
FDA device recall Z-1150-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- Reason for recall
- Some of the material has been found to be gelled and therefore becomes unusable.
- Action taken
- An "Urgent Medical Device Recall" letter and "Recall Return Form" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the "gelling" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KLE
- Quantity affected
- 1,400
- Distribution
- Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
- Date initiated
- 2009-08-24
- Date posted
- 2010-03-16
- Date terminated
- 2012-02-24
- 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 |
|---|---|---|
| DENTIN CONDITIONING AND ADHESIVE (BOND 1) (K973388) | Jeneric/Pentron, Inc. | 1997-09-12 |