Recall Z-1524-06 ยท EMA Cement, Dental
Kerr Corp
TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
| Date | Sep 23, 2006 (initiated Aug 14, 2006) |
| Status | Terminated |
| Reason | 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) |
| Root cause | Other |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982590 | TEMPBOND CLEAR-2 Sybron Dental Specialties, Inc., Oct 8, 1998 |