Events

Recall of FULL RADIUS

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
    19229
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-30
  • 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 is initiating a voluntary field corrective action/recall of various batches of the full radius blade 3.5mm due to a manufacturing error. the product was manufactured with a black ultem sluff chamber instead of a blue polycarbonate one. smith & nephew considers that the use or exposure to the product is unlikely to cause adverse health consequences. the colour of the sluff chamber is irrelevant to the clinical use and the material has no impact on the device performance. the device will perform as intended.

Device

FULL RADIUS
  • Model / Serial
    Model Catalog: 7205305 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    FULL RADIUS BLADE
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.