Events

Recall of AUTOSUTURE ENDO GIA II DISPOSABLE LOADING UNIT W/ TITANIUM STAPLES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by UNITED STATES SURGICAL A DIV. OF TYCO HEALTHCARE GROUP.

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
    41072
  • Event Risk Class
    II
  • Event Initiated Date
    2001-10-15
  • 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
    Certain lots loading units have a potential condition in wich a loading unit may transect without of the staples being placed into tissue.

Device

AUTOSUTURE ENDO GIA II DISPOSABLE LOADING UNIT W/ TITANIUM STAPLES

Manufacturer

UNITED STATES SURGICAL A DIV. OF TYCO HEALTHCARE GROUP
  • Manufacturer Address
    NORWALK
  • Source
    HC