Events

Recall of SPATIALFRAME.COM SOFTWARE

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
    32295
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-01
  • 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
    Smith & nephew had determined that under certain rare conditions the spatialframe software could produce a strut adjustment schedule with a duration longer than anticipated. strut adjustment schedules which were printed after selecting "save as' selecting the "prescription" tab and selecting "printable pdf version" between march 19 2011 and august 14 2011 may be affected. if the strut adjustment schedule goes unnoticed the bone may consolidate sooner than anticipated and may require additional surgery to re-fracture the bone.

Device

SPATIALFRAME.COM SOFTWARE
  • Model / Serial
    Model Catalog: 71070401 (Lot serial: VERSION 4.1.1)
  • Product Description
    SPATIALFRAME.COM SOFTWARE
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.