Events

Recall of MAYFIELD GEL PAD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTEGRA CANADA ULC..

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
    49905
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-27
  • 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
    A small number of our mayfield right & left gel pads were packaged incorrectly with the right gel pad in the left package and the left gel pad in the right package.

Device

MAYFIELD GEL PAD
  • Model / Serial
    Model Catalog: RIGHT GEL PAD # 440C1012 (Lot serial: Right Gel Pad: #093990); Model Catalog: LEFT GEL PAD #440C1011 (Lot serial: Left Gel Pad: #093984); Model Catalog: RIGHT GEL PAD # 440C1012 (Lot serial: Left Gel Pad: #093984); Model Catalog: LEFT GEL PAD #440C1011 (Lot serial: Right Gel Pad: #093990)
  • Product Description
    MAYFIELD RIGHT GEL PAD AND LEFT GEL PAD
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.