TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
FDA device recall Z-1524-06 · posted 2006-09-23 · Terminated
Recall details
- Recalling firm
- Kerr Corp
- Reason for recall
- Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)
- Action taken
- A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand
- Root cause
- Other
- Status
- Terminated
- Product code
- EMA
- Quantity affected
- 2,007
- Distribution
- Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.
- Date initiated
- 2006-08-14
- Date posted
- 2006-09-23
- Date terminated
- 2012-08-03
- 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 |