Events

Recall of REMOVAL TOOL FOR T-PAL

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
    96290
  • Event Risk Class
    II
  • 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
    Synthes was notified by its supplier that within one material batch used for production of the affected parts one or several bars were mixed in with an incorrect material. specified material was 420a and material of the mixed in bar(s) was x20crmnni 12 8 6 (which is a non-magnetic austenitic steel grade used for electric generators). the wrong material results in lower than specified hardness and corrosion resistance.

Device

REMOVAL TOOL FOR T-PAL
  • Model / Serial
    Model Catalog: 03.812.005 (Lot serial: T987623); Model Catalog: 03.632.087 (Lot serial: T987270)
  • Product Description
    REMOVAL TOOL FOR T-PAL
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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