Recall Z-1150-2010 ยท KLE Agent, Tooth Bonding, Resin
Sybron Dental Specialties
Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
| Date | Mar 16, 2010 (initiated Aug 24, 2009) |
| Status | Terminated |
| Reason | Some of the material has been found to be gelled and therefore becomes unusable. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1,400 |
| Distribution | Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand. |
| 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 |