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
    24678
  • Event Risk Class
    II
  • Event Initiated Date
    2006-04-20
  • 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
    Some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks severely compromising the knee function.

Device

TOTAL KNEE PROSTHETIC DEVICE
  • Model / Serial
    Model Catalog: TK1100 (Lot serial: 40074 40083 40103 40110); Model Catalog: TK1900 (Lot serial: 40074 40083 40103 40110); Model Catalog: TK2000 (Lot serial: 39945 39966 39973 40043); Model Catalog: TK1900 (Lot serial: 39945 39966 39973 40043); Model Catalog: TK1100 (Lot serial: 39945 39966 39973 40043); Model Catalog: TK2100 (Lot serial: 39637 39852 39941 39943); Model Catalog: TK2000 (Lot serial: 39637 39852 39941 39943); Model Catalog: TK1900 (Lot serial: 39637 39852 39941 39943); Model Catalog: TK1100 (Lot serial: 39637 39852 39941 39943); Model Catalog: TK2100 (Lot serial: 34032.); Model Catalog: TK2000 (Lot serial: 34032.); Model Catalog: TK1900 (Lot serial: 34032.); Model Catalog: TK1100 (Lot serial: 34032.); Model Catalog: TK2100 (Lot serial: 39179 39356 39365 39392); Model Catalog: TK2000 (Lot serial: 39179 39356 39365 39392); Model Catalog: TK1900 (Lot serial: 39179 39356 39365 39392); Model Catalog: TK1100 (Lot serial: 39179 39356 39365 39392); Model Catalog: TK2100 (Lot serial: 38953 38993 38998 3
  • Product Description
    TOTAL KNEE EXTERNAL LIMB COMPONENT KNE
  • Manufacturer
    OSSUR AMERICAS INC.

Manufacturer

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