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
    36222
  • Event Risk Class
    Class 2
  • Event Number
    Z-1524-06
  • Event Initiated Date
    2006-08-14
  • Event Date Posted
    2006-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48209
  • 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
    Low bonding performance: the affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured).
  • Action
    A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand

Device

Kerr TempBond Clear
  • Model / Serial
    Lot numbers: 444881 and 445348.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.
  • Product Description
    TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
  • Manufacturer
    Kerr Corp

Manufacturer

Kerr Corp
  • Manufacturer Address
    Kerr Corp, 1717 W Collins Ave, Orange CA 92867-5422
  • Source
    USFDA