Events

Avis De Sécurité sur rHead Radial Head / Uni-Elbow

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Stryker GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    The result of a review of the currently available stryker rhead radial head and uni-elbow data showed that there were no conclusive results further supporting the use of the device. because of this, we decided to withdraw the product from markets worldwide.   healthcare professionals working with patients using the stryker rhead radial head / uni-elbow prosthetic system should continue to monitor such patients in accordance with routine care standards, as no additional harm was detected.

Device

rHead Radial Head / Uni-Elbow

Manufacturer

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