Events

Recall of OSSCORA SURGICAL SET W/HANDPIECE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COCHLEAR 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
    46517
  • Event Risk Class
    III
  • Event Initiated Date
    2018-02-19
  • 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
    The supplier w&h dentalwerk burmoos notified cbas of a potential malfunction in the foot control included in osscora surgical set (part# 91053). foot control may not switch back to zero position when pedal is released-causing motor to continue rotation. drilling mode not affected. automatic torque stop fully functional.

Device

OSSCORA SURGICAL SET W/HANDPIECE
  • Model / Serial
    Model Catalog: 91053 (Lot serial: E01039)
  • Product Description
    Osscora Surgical Set
  • Manufacturer
    COCHLEAR CANADA INC.

Manufacturer

COCHLEAR CANADA INC.
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Cochlear Ltd.
  • Source
    HC