Events

Recall of Device Recall Bond1 Primer/Adhesive

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

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
    54490
  • Event Risk Class
    Class 2
  • Event Number
    Z-1150-2010
  • Event Initiated Date
    2009-08-24
  • Event Date Posted
    2010-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88580
  • 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
    Resin Tooth Bonding Agent - Product Code KLE
  • Reason
    Some of the material has been found to be gelled and therefore becomes unusable.
  • Action
    An "Urgent Medical Device Recall" letter and "Recall Return Form" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the "gelling" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Bond1 Primer/Adhesive
  • Model / Serial
    Lots 186620, 190582 and 190985.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
  • Product Description
    Bond-1 Primer/Adhesive. || The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Manufacturer Address
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA