Events

Recall of Elements Gutta Percha and Elements RealSeal Cartridges

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

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
    53812
  • Event Risk Class
    Class 2
  • Event Number
    Z-0488-2010
  • Event Initiated Date
    2009-10-27
  • Event Date Posted
    2009-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86569
  • 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
    Gutta Percha - Product Code EKM
  • Reason
    The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the elements obturation unit with which the cartridges are used. more specifically, there exists a possibility that if the lock nut were to fail, the cart.
  • Action
    The recall communications was initiated on November 06, 2009 with the firm forwarding a Recall Letter to the affected consignees via US Postal Service 1st class mail. The recall letter informed the consignees of the reason for recall, the hazard and the affected products. Consignees were instructed to call SybronEndo Customer Care at 1-800-346-3636 directly to handle returns & replacements. In addition, consignees were asked to complete the enclosed Recall Return Form and return it by fax to 909-962-5605. The recall notice also instructed consignees that are an authorized SybronEndo distributor to identify and recover the affected product lots listed above that may have been shipped to their customers.

Device

Elements Gutta Percha and Elements RealSeal Cartridges
  • Model / Serial
    Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide to: USA, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela
  • Product Description
    Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
  • Manufacturer
    Sybronendo

Manufacturer

Sybronendo
  • Manufacturer Address
    Sybronendo, 1717 W Collins Ave, Orange CA 92867
  • Source
    USFDA