Events

Retiro De Equipo (Recall) de Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2018-RN-00280-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-03
  • 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-2018-RN-00280-1
  • 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
    Stryker has received a report that a hinge pin disassociated from the mako onlay insert extractor. in that reported case, the disassociated hinge pin was discovered prior to the device being used in surgery and a backup device was available and subsequently used to complete the procedure. in the event of an undetected disassociated hinge pin, the potential hazards include the hinge pin being left in the wound or excessive metal wear giving rise to debris. to date, there have been no injuries reported as a result of this issue.
  • Acción
    Stryker is advising users to inspect stock and return any remaining units of the affected lot numbers.

Device

Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)
  • Modelo / Serial
    Mako Onlay Insert Extractor (part of the Restoris MCK (Multi Compartmental Knee) Unicondylar System)Item Number: 160430Lot Numbers: 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016,19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26130512, 26170513, 26201111, 26290412, 26440912ARTG Number: 223107
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA