Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N
FDA device recall Z-1142-2012 · posted 2012-03-02 · Terminated
Recall details
- Recalling firm
- Kerr Corporation
- Reason for recall
- The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable.
- Action taken
- Pentron Clinical sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 7, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to complete and return an enclosed Recall Return Form via fax at 1-877-677-8844. Contact Pentron Clinical Customer Service at (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
- 30,276 units total
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand,
- Date initiated
- 2010-05-27
- Date posted
- 2012-03-02
- Date terminated
- 2012-03-02
- 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 |