Events

Recall of MICROSEAL GUTTA PERCHA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYBRON DENTAL SPECIALTIES INC..

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
    62528
  • Event Risk Class
    III
  • Event Initiated Date
    2010-09-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Outer box 815-9033 (purple microseal master cone) contained 815-9032 (red microseal master cone). if tooth is prepared for .04 taper point & a .02 point is used point could go past apex and possibly lead to periodontal inflammation requiring a retreat.Us.

Device

MICROSEAL GUTTA PERCHA
  • Model / Serial
    Model Catalog: 815-9033 (Lot serial: 111507); Model Catalog: 815-9033 (Lot serial: 082307)
  • Product Description
    Microseal Master Cones
  • Manufacturer
    SYBRON DENTAL SPECIALTIES INC.

Manufacturer

SYBRON DENTAL SPECIALTIES INC.