Recall Z-1142-2012 ยท KLE Agent, Tooth Bonding, Resin
Kerr Corporation
Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB Bond-1 Primer/Adhesive 6ml N04 Lute-it w/ Bond-1 kit N04B Lute-t w/Bond-1 Intro Kit N31B Bond-1 C&B Prim/Adhesive N33 Cement-it Univer
| Date | Mar 2, 2012 (initiated May 27, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Sp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) Jeneric/Pentron, Inc., Sep 12, 1997 |