Events

Recall of Bisco BISCEM SelfAdhesive Resin Cement Opaque

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bisco Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    47871
  • Event Risk Class
    Class 2
  • Event Number
    Z-1697-2008
  • Event Initiated Date
    2008-04-28
  • Event Date Posted
    2008-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70388
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dental Cement - Product Code EMA
  • 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.
  • 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.

Device

Bisco BISCEM SelfAdhesive Resin Cement Opaque
  • Model / Serial
    all lots of Item numbers D-45012P and D-45002S
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    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.
  • Manufacturer
    Bisco Inc

Manufacturer

Bisco Inc
  • Manufacturer Address
    Bisco Inc, 1100 W Irving Park Rd, Schaumburg IL 60193-3569
  • Manufacturer Parent Company (2017)
    Bisco Inc.
  • Source
    USFDA