Events

Recall of OSSEOCARE PRO CA 20:1 L MS KM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOBEL BIOCARE 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
    83517
  • Event Risk Class
    I
  • Event Initiated Date
    2013-10-25
  • 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
    Nobel biocare has become aware through customer complaint from spain that when using the osseocare pro ipad application release 1.2.0.7 the grey button located on the foot pedal has no effect on the rotation direction. pressing the grey button normally sets the motor in reverse rotation mode. however when pressing the grey button with the software release 1.2.0.7 this does not change the rotation direction.

Device

OSSEOCARE PRO CA 20:1 L MS KM
  • Model / Serial
    Model Catalog: 1700471 (Lot serial: >10 numbers contact mfg); Model Catalog: 1700471 (Lot serial: >10 CONTACT MANUFACTURER)
  • Product Classification
    Dental Devices
  • Product Description
    OSSEOCARE PRO CA 20:1 L MS KM
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC