Retiro De Equipo (Recall) de Acumed Tension Band Pin

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Acumed LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Ortho Medics Limited, 586 Great South Road, Ellerslie, Auckland 1051
  • Causa
    This implantable product was manufactured wiht a grade of stainless steel that is different than from what was specified. cytotoxicity tests confirm that product is not cytotoxic. additional biocompatibility testing is currently underway. to date there have been no reported injuries and one malfunction with no harm to patient. the root cause of the malfunction is as yet inknown.
  • Acción
    Product to be returned to supplier


  • Modelo / Serial
    Model: TB-1550K-S TB-1570K-S TB-1590K-S, Affected: Manufactured between Jan 2009 and March 2011
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source