Events

Recall of T4/T5 TOGA

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

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
    70263
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-14
  • 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
    Through an investigation into complaints about the delamination (polyethylene layer separating from sms layer) stryker instruments discovered that rolls of raw material from stryker's supplier had burst test values below (less than 3psi) the specifications set by stryker (minimum of 3psi). as such raw materials received from the supplier were not within specification leading to a potential for delamination (separation of material layers) to occur.

Device

T4/T5 TOGA
  • Model / Serial
    Model Catalog: 0400-850-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 0400-820-000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 0400-820-100 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    T4/T5 TOGA
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC