Events

Retiro De Equipo (Recall) de DePuy S-ROM Noiles Rotating Hinge Femur with Pin

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

¿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-2014-RN-00939-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-27
  • 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-2014-RN-00939-1
  • 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
    In march, 2014, johnson & johnson medical pty. ltd (jjm) issued recall for product correction letter (tga ref.: rc-2014-rn-00355-1) for the s-rom noiles rotating hinge femur with pin devices as the company had identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin. the new packaging design is complete and products are available with the new packaging. therefore, johnson & johnson medical pty ltd is recalling the products with the previous packaging from the market.
  • Acción
    Customers are advised not to use the affected inventory. Replacement product with the new packaging will be supplied for the affected stock. This action has been closed-out on 06/06/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin
  • Modelo / Serial
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAffected lots: 314827, 464645, 438249 & 378650ARTG number: 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia