Events

Recall of DRILL BIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNTHES (CANADA) LTD..

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
    14840
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-14
  • 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
    Synthes (canada) ltd. is initiating a medical device recall for the drill bit due to the potential for the drill stop to slip on the reamer. if the drill stop slips on the reamer it may cause deeper reaming than intended and in rare cases penetration of the joint space causing pain and/or joint irritation.

Device

DRILL BIT
  • Model / Serial
    Model Catalog: 03.010.228 (Lot serial: ALL LOTS)
  • Product Description
    DRILL BIT
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC