Events

Recall of LEGION HINGE KNEE SYSTEM FEMORAL W/AXLE RIGHT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW 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
    83547
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-07
  • 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
    Smith & nephew inc. has initiated a voluntary field safety corrective action of the legion hk femoral assembly due to a manufacturing issue. the surface inside of the femoral component where cement is applied for adhesion is out of specification. the expected surface roughness is 200-325 ra. the affected devices are below allowable limits for surface roughness.

Device

LEGION HINGE KNEE SYSTEM FEMORAL W/AXLE RIGHT
  • Model / Serial
    Model Catalog: 71421365 (Lot serial: 15KM09011); Model Catalog: 71421365 (Lot serial: 15KM08949)
  • Product Description
    LEGION HINGE KNEE (HK) FEMORAL ASSEMBLY
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.