Events

Avis De Sécurité sur BIOLOX FORTE 36mm Alumina ceramic heads

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 MicroPort Orthopedics.

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
  • Date
    2017-02-08
  • 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
    Microport orthopedics has initiated a voluntary field safety corrective action for biolox forte 36mm alumina ceramic heads. implants will be updated with a label which will state the numerical offset of the ceramic head instead of the current labelling (short, medium, long). the intent of this letter is to inform you of all known risks potentially associated with the use of the products affected by this voluntary field safety corrective action and list any action to be taken by you. .

Device

BIOLOX FORTE 36mm Alumina ceramic heads

Manufacturer

MicroPort Orthopedics