Events

Notificaciones De Seguridad De Campo acerca de trial femoral head dia.40mm

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Limacorporate spa.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-09-12
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    This notice needs to be passed on all those who need to be aware within Your organization, or to any organization where the potentially affected devices have been transferred. This Field Safety Notice will be sent to the Competent Authorities of the Countries involved (Italia, Slovenia and Spain). // FSCA ID: 9095.10.744
  • Causa
    An internal analysis performed in limacorporate showed a slight dimensional anomaly on the female taper of the trial femoral heads dia.40mm (product code 9095.10.744) with specific lot # 15am0af. in detail, on a total of 39 trial heads measured with lot # 15am0af, 12 of these trial heads showed a slight over-dimensioning of the female taper diameter. if present, this slight dimensional anomaly may cause an instable coupling between the trial head (female taper) and the trial neck (male taper) intra-operatively, when the surgeon uses these trial devices in order to define the correct size of the final hip implant. limacorporate did not receive any complaint on the lot # 15amoaf. therefore this recall action is a preventive action.

Device

trial femoral head dia.40mm
  • Modelo / Serial
    15AM0AF
  • Descripción del producto
    Trial device for hip prosthesis
  • Manufacturer
    Limacorporate spa

Manufacturer

Limacorporate spa
  • Dirección del fabricante
    Via Nazionale, 5233038 Villanova di San Daniele Udine - Italy T. +39 0432 945511 F. +39 0432 945512 info@limacorporate.com www.limacorporate.com • REA Nr. 173824 Cap. Soc. Euro 09.837.283,00 i.v. C.F. e P.IVA IT01427710304
  • Empresa matriz del fabricante (2017)
    Emil Holding Ii Sarl
  • Source
    AMPMDRS