Events

Recall of UNIGLIDE TIBIA CEMENTLESS COCR

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

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
    25884
  • Event Risk Class
    III
  • Event Initiated Date
    2009-08-28
  • 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
    Insufficient process control of the sterile barrier (blister lid) sealing process. the devices have been sealed in blister packs. pack test results from one day's production met minimum requirements of the testing regime but there was a step change in the test results indicating a change to the validated process.

Device

UNIGLIDE TIBIA CEMENTLESS COCR
  • Model / Serial
    Model Catalog: 525.0700 (Lot serial: NACN)
  • Product Description
    UNIGLIDE TIBIA CEMENTLESS SIZE 7
  • Manufacturer
    CORIN LIMITED

Manufacturer

CORIN LIMITED