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FDA Enforcement Report

Excerpted from the U.S. Food and Drug Administration's Sept. 3, 2008, Enforcement Report:

PRODUCT
a) 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, Item numbers D-45011P, D-45001S and G-91700K, Recall # Z-1696-2008;
b) 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; Item numbers D-45012P and D-45002S, Recall # Z-1697-2008;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Bisco, Inc., Schaumburg, IL, by letters dated April 25, 2008. Firm initiated recall is ongoing.
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.
VOLUME OF PRODUCT IN COMMERCE
69,847 syringes
DISTRIBUTION
Nationwide and Internationally