Events

Recall of FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL

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

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
    53673
  • Event Risk Class
    Class 2
  • Event Number
    Z-0482-2010
  • Event Initiated Date
    2009-10-22
  • Event Date Posted
    2009-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86306
  • 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
    Temporary crown and bridge resin - Product Code EBG
  • Reason
    Pentron clinical technologies llc received two (2) complaints alleging that the tempspan dual-cure temporary crown and bridge material was not setting. investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
  • Action
    The recall customer notification was initiated on October 22, 2009 with the firm forwarding an urgent medical device letter with recall return form via USPS first class mail to the affected consignees. The letter informed the consignees of the reason for recall and instructed them to return any used or unused product of the affected lot. The firm provided an 800 number for the consignees to call to arrange for product return and replacement.

Device

FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
  • Model / Serial
    Lot Number 191691
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, || The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
  • Manufacturer
    Jeneric/Pentron

Manufacturer

Jeneric/Pentron
  • Manufacturer Address
    Jeneric/Pentron, 68 N Plains Industrial Rd, Wallingford CT 06492
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA