Recall Z-1696-2008 ยท EMA Cement, Dental
Bisco Inc
Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp.
| Date | Aug 25, 2008 (initiated Apr 28, 2008) |
| Status | Terminated |
| Reason | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time. |
| Root cause | Incorrect or no expiration date |
| Action | Bisco sent Urgent Medical Device recall letters dated 4/25/08 to the U.S. consignees via 1st class mail on 4/28/08. The letters informed the users that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Future production lots will be labeled with a shelf life of 1 year with a requirement to refrigerate the product when not in use. The accounts were requested to destroy their remaining stocks of the product and record the number of used or partially used syr |
| Distribution | Nationwide including Puerto Rico and internationally to Argentina, Australia, Bulgaria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE Bisco, Inc., May 15, 2006 |