Recall Z-1697-2008
Bisco Inc · initiated April 28, 2008
Product
Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; 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.
Codes / lots: all lots of Item numbers D-45012P and D-45002S
Reason for recall
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.
FDA-determined cause: Incorrect or no expiration date
Action taken
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 syringes destroyed, indicating the lot numbers of the units destroyed on the enclosed response form and fax it back to Bisco at 847-534-66101. Questions were directed to Bisco Dental Products Customer Service at 1-800-247-3368.
Details
- Recall number
- Z-1697-2008
- Initiated
- April 28, 2008
- Posted by FDA
- August 25, 2008
- Terminated
- September 14, 2010
- Product code
- EMA – Cement, Dental
- 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, Netherlands, Norway, New Zealand, Peru, Philippines, Portugal, Romania, Saudi Arabia, Serbia, Singapore…
- Recalling firm
- Bisco Inc, Schaumburg, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1696-2008 | Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The…During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive… | 04/28/2008Terminated |