Events

Recall of SCHANZ SCREW SELF DRILLING

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

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
    34788
  • Event Risk Class
    II
  • Event Initiated Date
    2017-09-19
  • 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 item is being recalled due to an inadequate pouch seal. this defect has the potential to lead to a loss of sterile pouch integrity which could impact the product's sterility assurance and may lead to serious adverse events such as infections both localized and systemic.

Device

SCHANZ SCREW SELF DRILLING
  • Model / Serial
    Model Catalog: 20070057 (Lot serial: 1723305)
  • Product Description
    SCHANZ SCREW SELF DRILL
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD