Tooth bonding resin. Premise Master Syringe Kit, Part Number 32611, Lot Numbers 428730
FDA device recall Z-0691-06 · posted 2006-03-28 · Terminated
Recall details
- Recalling firm
- Kerr Corp
- Reason for recall
- The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Action taken
- 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 that they may have shipped to their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- KLE
- Quantity affected
- 10
- Distribution
- Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.
- Date initiated
- 2006-03-03
- Date posted
- 2006-03-28
- Date terminated
- 2012-03-07
- 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 |
|---|---|---|
| OPTIBOND SOLO PLUS 2 (K991808) | Sybron Dental Specialties, Inc. | 1999-07-09 |