Events

Recall of CUSA EXCEL+ SYSTEM - NOSECONE AND SWITCHCOVERS

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
    55234
  • Event Risk Class
    III
  • Event Initiated Date
    2013-01-07
  • 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
    The purpose of this field safety notice is to inform affected customers of cusa tip breakage issue when using a cem nosecone models c6623 or c6636 with the cusa excel/excel+ ultrasonic aspirator and to provide an updated cem nosecone ifu with an additional warning information.

Device

CUSA EXCEL+ SYSTEM - NOSECONE AND SWITCHCOVERS
  • Model / Serial
    Model Catalog: C6623 (Lot serial: ALL NON EXPIRED LOTS); Model Catalog: C6636 (Lot serial: ALL NON EXPIRED LOTS)
  • Product Description
    CUSA EXCEL+ SYSTEM - NOSECONE AND SWITCHCOVERS
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.