Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a tem

FDA device recall Z-1696-2008 · posted 2008-08-25 · Terminated

Recall details

Recalling firm

Bisco Inc

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.

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

EMA

Distribution

Nationwide including Puerto Rico and internationally to Argentina, Australia, Bulgaria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemal

Date initiated

2008-04-28

Date posted

2008-08-25

Date terminated

2010-09-14

Location

Schaumburg, IL

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