Events

Retiro De Equipo (Recall) de Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Lima Orthopaedics Australia 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-01053-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-10
  • 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-01053-1
  • 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
    The manufacturer, limacorporate has received two complaints about the allen wrench. firstly, the impossibility to connect the allen wrench to the t-handle intra-operatively. secondly, after a difficult insertion, it was impossible to remove the allen wrench from the t-handle. in both cases, there were no reported consequences for the patients. limacorporate's investigations have shown that the diameter of the zimmer connection on the allen wrench has been manufactured out of specification and is over-dimensioned. this leads to difficult/impossible coupling between the allen wrench and the t-handles.
  • Acción
    Lima Orthopaedics' kit coordinator will be visiting hospitals and replacing affected devices in the SMR instrument sets with unaffected devices. This action has been closed-out on 20/02/2017.

Device

Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation ...
  • Modelo / Serial
    Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)Allen Wrench 5mmProduct Code: 9013.50.210Lot Number: 14AA311 SMR instrument setProduct Codes: 9013.23.000, 9013.43.000, 9013.45.000ARTG Number: 176592
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd