Events

Recall of ARTHROWAND MICROBLATOR W/INTEGRATED CABLE W/O SUCTION

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
    56358
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-25
  • 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
    During functional testing it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels. this action is due to product misbranding. the expiration date is not supported by the real time aging collected. there are no associated immediate or long range health consequences anticipated from the use of or exposure to the defective device.

Device

ARTHROWAND MICROBLATOR W/INTEGRATED CABLE W/O SUCTION
  • Model / Serial
    Model Catalog: AC4040-01 (Lot serial: 1032755)
  • Product Description
    ARTHROWAND TOPAZ MICRODEBRIDER W/INTEGRATED CABLE W/O SUCTION
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.