Recall Z-0691-06 ยท KLE Agent, Tooth Bonding, Resin
Kerr Corp
Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730
| Date | Mar 28, 2006 (initiated Mar 3, 2006) |
| Status | Terminated |
| Reason | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Root cause | Other |
| Action | A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product th |
| Quantity | 10 |
| Distribution | Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991808 | OPTIBOND SOLO PLUS 2 Sybron Dental Specialties, Inc., Jul 9, 1999 |