Events

Recall of Kerr TempBond Clear

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

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
    53296
  • Event Risk Class
    Class 3
  • Event Number
    Z-0074-2010
  • Event Initiated Date
    2009-09-09
  • Event Date Posted
    2009-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85216
  • 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
    Cement, dental - Product Code EMA
  • Reason
    The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
  • Action
    Kerr Corporation issued an "Urgent Medical Device Recall" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.

Device

Kerr TempBond Clear
  • Model / Serial
    Part Number 33351, Lot Numbers: 3252902, 3229807, 3268505, 3277455, 3257280, 3258772 and 3269811.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.
  • Product Description
    Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. || Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.
  • Manufacturer
    Kerr Corp

Manufacturer

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