Events

Recall of GENESIS II M/B KNEE SYSTEM

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
    50779
  • Event Risk Class
    II
  • Event Initiated Date
    2006-05-01
  • 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
    Loosening of the rotation peg from the tibial base plate.

Device

GENESIS II M/B KNEE SYSTEM
  • Model / Serial
    Model Catalog: 7156-5611 IMPACTOR (Lot serial: all lots); Model Catalog: 7156-5619 TORQUE WRENCH (Lot serial: all lots)
  • Product Description
    GENESIS II MB KNEE INSTRUMENTS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.