Events

Alerte De Sécurité sur female adapters on prosthetic feet

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Ossur.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-07-16
  • Date de publication de l'événement
    2015-07-16
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150716_2.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ossur Female Adapters on Prosthetic Feet
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    DH