Events

Recall of Device Recall TempSpan CMT Temporary Cement

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
    61270
  • Event Risk Class
    Class 2
  • Event Number
    Z-1205-2012
  • Event Initiated Date
    2011-03-03
  • Event Date Posted
    2012-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107695
  • 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 pentron clinical has confirmed that the tempspan temporary cement may have black plastic material on the surface of the paste, and it may set faster than specified.
  • Action
    Pentron Clinical sent an Urgent Medical Device Recall letter dated April 20, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax back the enclosed recall form to 1-877-677-8844 in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer Service at (800) 551-0283, option 1, directly to handle the arrangements of a quick return and replacement. For questions regarding this recall call 714-516-7400.

Device

Device Recall TempSpan CMT Temporary Cement
  • Model / Serial
    Lot Number: 3748413
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.
  • Product Description
    Brand Name: TempSpan CMT Temporary Cement, a temporary cement. || Part Number: N69CA. || The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.
  • 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