Recall Z-1521-06 ยท KLE Agent, Tooth Bonding, Resin
Kerr Corp
OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
| Date | Sep 23, 2006 (initiated Aug 29, 2006) |
| Status | Terminated |
| Reason | Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength. |
| Root cause | Other |
| Action | A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. 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 that they may have shipped to their customers. Periodic effectiveness checks will be conducted in order to follow up with non-responders. |
| Quantity | 247 Kits (50 unidose pouches/Kit) |
| Distribution | World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom |
| FDA record | Open on fda.gov |