Events

Recall of Microseal Master Cone Part Number: 8159033

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ormco 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
    57234
  • Event Risk Class
    Class 3
  • Event Number
    Z-0160-2012
  • Event Initiated Date
    2010-09-09
  • Event Date Posted
    2011-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95651
  • 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 sybronendo has confirmed that the microseal master cones has been mislabeled.
  • Action
    Sybron Dental Specialties, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return the affected lots of product.. Products, would be replaced at no charge or credited to their account. Customers were instructed to contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement. The affected product should be returned to SybronEndo at the following address. Please label returned product "RECALLED PRODUCT Attention: Customer Returns" SybronEndo 1332 South Lone Hik Avenue Glendora, CA 91740 ADDITIONALLY, THEY KINDLY REQUEST CONSIGNEE COOPERATION IN COMPLETING AND FAXING BACK THE ENCLOSED ACKNOWLEDGEMENT/RETURN FORM. THIS FORM MUST BE COMPLETED AND RETURNED WHETHER OR NOT YOU HAVE ANY PRODUCT TO RETURN. Customers were also asked to identify and recover the affected product lots listed above that may have been shipped to their customers. For questions regarding this recall call 909-962-5600.

Device

Microseal Master Cone Part Number: 8159033
  • Model / Serial
    Lot Numbers: 111507, 082307
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AR, CA, FL, PA, GA, IL, TX, WA, NY, IN, AL & MT; Internationally to Canada, CIS (Commonwealth of Independent States, Israel, United Kingdom, Sweden, France, Germany, and Italy.
  • Product Description
    Microseal Master Cone Part Number: 815-9033 || Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation
  • Manufacturer Address
    Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA