Retiro De Equipo (Recall) de ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)

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-2013-RN-01033-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-04
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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 complaints associated with cracks and/or fractures of the ball impactor tip and rim impactor tip instruments. the potential hazards include;- cracked or fractured ball impactor tip/rim impactor tip- loose fragments form the ball impactor tip/rim impactor tip- insufficient locking strength of the mdm liner (ball impactor tip only).
  • Acción
    Stryker is releasing updated surgical procedures and also updating the loan dockets, recommending the use of a slotted mallet to be used to impact the impactor handle, and emphasising that all tips should be inspected for deformation and cracks before use.

Device

  • Modelo / Serial
    ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)ADM/MDM Ball Impactor TipCatalogue Numbers: 12350013 (12350303A-T, 12350306-T, 12350306V-T, 12350306C-T) ADM Rim Impactor TipCatalogue Numbers: 12350014 (12350303A-T)All Lot Numbers AffectedARTG Number: 181721
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA