Events

Retiro De Equipo (Recall) de PyroTitan Humeral Resurfacing Arthroplasty Shapers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LMT Surgical Pty Ltd.

¿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
    Recall
  • ID del evento
    RC-2016-RN-00091-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00091-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    It has been determined that certain affected lots of non-conforming product may not be as sharp as intended by design.This may be evident during use by having to increase the applied force to the shaper needed to cut and form the humeral head effectively for the placement of the implant. this increase in force can in-turn, which could create undesirable friction between the shaper and the humeral head that could potentially result in bone tissue being burned.
  • Acción
    Integra LifeSciences is advising users that affected stock can be used if there are no alternatives available. Affected stock will be replaced with unaffected units.

Device

PyroTitan Humeral Resurfacing Arthroplasty Shapers
  • Modelo / Serial
    PyroTitan Humeral Resurfacing Arthroplasty ShapersMultiple Catalogue and Lot Numbers affectedARTG Number: 111050
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd