Events

Recall of SPIRIT 3000 DENTAL CHAIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HENRY SCHEIN CANADA 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
    67610
  • Event Risk Class
    III
  • Event Initiated Date
    2011-04-06
  • 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
    Pelton & crane became aware via 3 internal failures in production that the link arm assembly that connects some rear mounted options (cuspidors assistants instrumentation and hygiene systems) to the spirit 3000 dental chair may potentially break and fall off the dental chair.

Device

SPIRIT 3000 DENTAL CHAIR
  • Model / Serial
    Model Catalog: 3004 (Lot serial: 16934); Model Catalog: 3003 (Lot serial: 16964); Model Catalog: 3004 (Lot serial: 16964); Model Catalog: 3003 (Lot serial: 16934)
  • Product Description
    SPIRIT 3000 DENTAL CHAIR
  • Manufacturer
    HENRY SCHEIN CANADA INC.

Manufacturer

HENRY SCHEIN CANADA INC.
  • Manufacturer Address
    NIAGARA-ON-THE-LAKE
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    HC