Events

Recall of VALOR SCREW 5.0MM LEN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WRIGHT MEDICAL TECHNOLOGY CANADA 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
    65793
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-09
  • 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
    Wright medical technology is conducting a recall of certain sterile products due to a lack of adequate documentation confirming sterility. the affected sterile products are intended for use in the lower extremities. implanting non-sterile products can lead to potential risks such as infection.

Device

VALOR SCREW 5.0MM LEN
  • Model / Serial
    Model Catalog: 4151150045 (Lot serial: 1547961); Model Catalog: 200011901 (Lot serial: 1540433)
  • Product Description
    VALOR SCREW 5.0MM X 45MM LENGTH;INBONE STEM TIBIAL TOP
  • Manufacturer
    WRIGHT MEDICAL TECHNOLOGY CANADA LTD

Manufacturer

WRIGHT MEDICAL TECHNOLOGY CANADA LTD