Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, tempora
FDA device recall Z-0074-2010 · posted 2009-10-23 · Terminated
Recall details
- Recalling firm
- Kerr Corp
- Reason for recall
- The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
- Action taken
- Kerr Corporation issued an "Urgent Medical Device Recall" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EMA
- Quantity affected
- 13,518 units
- Distribution
- Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.
- Date initiated
- 2009-09-09
- Date posted
- 2009-10-23
- Date terminated
- 2011-12-12
- 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 |
|---|---|---|
| TEMPBOND CLEAR-2 (K982590) | Sybron Dental Specialties, Inc. | 1998-10-08 |