Events

Avis De Sécurité sur Affinis Fracture, Inverse, and Short implants with Ti/CaP coating

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 Mathys Ltd Bettlach.

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
    2016-05-31
  • 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
    Mathys ltd bettlach has detected an inconsistency in the shelf-life of implants coated with titanium/calcium phosphate (ti/cap). as a preventive measure, the shelf-life of the ti/cap coated implants has been reduced from previously ten years to a new shelf-life of five years. for this reason, all the stocks of affected implants have been relabelled accordingly. .

Device

Affinis Fracture, Inverse, and Short implants with Ti/CaP coating

Manufacturer

Mathys Ltd Bettlach