Events

Recall of VITRAX II (SODIUM HYALURONATE)

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

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
    120374
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-06
  • 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 vitrax ii product is being recalled because during routine stability testing it was discovered that a sample tested at the three month time point had a ph value of 7.70 which exceeded the ph specification range of 6.8 to 7.5 resulting in a lab investigation. the investigation revealed that some units from different lots post eto sterilization have a ph greater than the upper ph limit of 7.5. the highest value was found to be 8.29.

Device

VITRAX II (SODIUM HYALURONATE)
  • Model / Serial
    Model Catalog: VT465 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    VITRAX II (SODIUM HYALURONATE)
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY