Events

Recall of WECK EFX SHIELD FASCIAL CLOSURE SYSTEM

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

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
    127116
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-18
  • 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 device's wings may partially detached from the efx shield during use. the wings are secured to the device at two points therefore they are not completely detaching from the device. the partial detachment makes removal of the device from the patient more difficult and there is potential the incision site may need to be enlarged in order to remove the device.

Device

WECK EFX SHIELD FASCIAL CLOSURE SYSTEM
  • Model / Serial
    Model Catalog: EFX002 (Lot serial: 3270100000); Model Catalog: EFX002 (Lot serial: 3269990000); Model Catalog: EFX002 (Lot serial: 3264480000)
  • Product Description
    Weck EFX Endo Facial Closure System
  • Manufacturer
    TELEFLEX MEDICAL

Manufacturer

TELEFLEX MEDICAL