Events

Recall of TOTAL KNEE PROSTHETIC DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OSSUR AMERICAS 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
    20244
  • Event Risk Class
    II
  • Event Initiated Date
    2009-08-31
  • 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 total knee junior is rated at 45kg. ossur initiated internal test limits of 65kg or 144% rated load in 2003. the current balancing unit drawing does not have a sufficient safety margin to assure that the devices will pass the 60kg test when the component is machined tominimum material condition.

Device

TOTAL KNEE PROSTHETIC DEVICE
  • Model / Serial
    Model Catalog: TK1100 (Lot serial: SERIAL 8573)
  • Product Description
    TOTAL KNEE PROSTHETIC DEVICE
  • Manufacturer
    OSSUR AMERICAS INC.

Manufacturer

OSSUR AMERICAS INC.
  • Manufacturer Address
    FOOTHILL RANCH
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    HC