Events

Recall of E-PEN - BURR ATTACHMENT

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
    28354
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-10
  • 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. received notification from its supplier synthes gmbh that a medical device recall was being initiated for part number(05.001.046) lot number (8230998) due to incorrect labelling of the device. this voluntary recall of the burr attachment m is used with synthes electric pen drive and air pen drive systems. one delivery of burr attachment l were marked with the marking of an "m" and that burr attachment m were marked with the marking of an "l".

Device

E-PEN - BURR ATTACHMENT
  • Model / Serial
    Model Catalog: 05.001.046 (Lot serial: 8230998)
  • Product Description
    E-PEN - BURR ATTACHMENT
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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