Events

Alerte De Sécurité sur rHead Radial Head and Uni-Elbow System

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

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
    2017-10-27
  • Date de publication de l'événement
    2017-10-27
  • 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_20171027a.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: stryker gmbh rhead radial head and uni-elbow system medical device manufacturer, stryker gmbh, has issued a medical device safety alert concerning its rhead radial head and uni-elbow system. according to the manufacturer, the result of a review of the currently available data of the stryker rhead radial head and uni-elbow system was found to be inconclusive to continue supporting the performance of the device. consequently, the manufacturer has decided to remove the product from the global markets. health care professionals that have patients using the stryker rhead radial head / uni-elbow prosthesis system should continue to follow up those patients in accordance with the routine standard of care. 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 27 october 2017.

Device

rHead Radial Head and Uni-Elbow System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Stryker GmbH rHead Radial Head and Uni-Elbow System
  • Manufacturer
    Stryker GmbH

Manufacturer

Stryker GmbH
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH