Events

Safety Alert for female adapters on prosthetic feet

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ossur.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-07-16
  • Event Date Posted
    2015-07-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150716_2.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ossur female adapters on prosthetic feet medical device manufacturer, ossur, has issued a medical device safety alert concerning its female adapters on prosthetic feet. the affected devices are identified as follow: talux, vari-flex, vari-flex xc, re-flex shock, re-flex rotate cat 7 sizes 28 – 30; cat 8 sizes 25 – 30; cat 9 all sizes flex-foot assure, balance foot j cat 4 size 30; cat 5 all sizes the manufacturer’s recent findings suggest that non-össur female mating adapters connected to össur ankle male pyramids have caused early failure of the male pyramid connector. this is due to incompatible geometry of the female mating adapters used and/ or improper set up of the prosthesis. affected users are advised to follow proper set-up procedure according to the instructions for use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 july 2015.

Device

female adapters on prosthetic feet
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ossur Female Adapters on Prosthetic Feet
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    DH