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U.S. Department of Health and Human Services

Class 2 Device Recall Bisco BISCEM SelfAdhesive Luting Cement Translucent

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  Class 2 Device Recall Bisco BISCEM SelfAdhesive Luting Cement Translucent see related information
Date Initiated by Firm April 28, 2008
Date Posted August 25, 2008
Recall Status1 Terminated 3 on September 14, 2010
Recall Number Z-1696-2008
Recall Event ID 47871
510(K)Number K060701  
Product Classification Dental Cement - Product Code EMA
Product 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.
Code Information all lots of Item numbers D-45011P, D-45001S and G-91700K
Recalling Firm/
Manufacturer		 Bisco Inc
1100 W Irving Park Rd
Schaumburg IL 60193-3569
For Additional Information Contact Mr. Ted Buckley
847-534-6030
Manufacturer 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 2		 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 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.
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, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vietnam
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EMA and Original Applicant = BISCO, INC.
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