Events

Recall of APEX UNIVERSAL IRRIGATION SYSTEM

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

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
    79556
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-29
  • 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
    Through the conmed linvatec complaint handling system conmed linvatec has received complaints for "won't sense pressure" on the item numbers c7120 and c7122. the issue was confirmed through in-house testing. it was determined that an internal assembled component (molded fitting part number a41-001-007 fitting pcv barb-female) contained a scratch/grooved area on the inside diameter of the fitting that may cause the apex irrigation pump to sense a pressure drop and increase fluid flow to the surgical site.

Device

APEX UNIVERSAL IRRIGATION SYSTEM
  • Model / Serial
    Model Catalog: C7120 (Lot serial: 1302144); Model Catalog: C7122 (Lot serial: 1302144); Model Catalog: C7122 (Lot serial: 1302284); Model Catalog: C7120 (Lot serial: 1302284)
  • Product Description
    APEX Arthroscopy Tubing Set One & Two Connection
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC