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 Kerr Corporation.

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
    61265
  • Event Risk Class
    Class 3
  • Event Number
    Z-1142-2012
  • Event Initiated Date
    2010-05-27
  • Event Date Posted
    2012-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107686
  • 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
    Agent, tooth bonding, resin - Product Code KLE
  • Reason
    The recall was initiated because pentron clinical has confirmed that various lots of bond-1 primer/adhesive have been found to have gelled and therefore becomes unusable.
  • Action
    Pentron Clinical sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 7, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to complete and return an enclosed Recall Return Form via fax at 1-877-677-8844. Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Bond1 Primer/Adhesive
  • Model / Serial
    Item # Bottle Lot # Package Lot# N01I 185597, 192338, 202233 186658, 194491, 202885 N01IAA 185597, 192372 184876, 185342, 192372 N01IAB 183352, 183845, 202233 183466, 183948, 203221 N04 191010 200816 N04B 185597 183127 N31B 184256, 197303 184464, 204774 N33 184256 180766
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Spain, Russia, Finland, England, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Romania, Sweden, and Serbia.
  • Product Description
    Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding || agent. || Item # Item Description || N01I Bond-1 Prim/Adhesive Kit || N01IAA Bond-1 Primer/Adhesive 4ml || N01IAB Bond-1 Primer/Adhesive 6ml || N04 Lute-it w/ Bond-1 kit || N04B Lute-t w/Bond-1 Intro Kit || N31B Bond-1 C&B; Prim/Adhesive || N33 Cement-it Universal C&B; Resin. || 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
    Kerr Corporation

Manufacturer

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