Events

Recall of CGS3000 GUIDED SURGERY KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS 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
    56615
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-01
  • 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
    Manufacturer determined that the cgs3000 guided surgery kit was assembled using two (2) cgs-pbidhs cgs implant-level driver handpiece 5.8mm short instruments instead of one (1) each cgs-pbidhs and one (1) cgs-pgidhs cgs implant-level driver handpiece 4.6mm short in position #52.

Device

CGS3000 GUIDED SURGERY KIT

Manufacturer

BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS INC.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    HC