Events

Retiro De Equipo (Recall) de Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-2014-RN-01366-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-24
  • 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-01366-1
  • 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 cheek retractor for matrixmandible u-shaped may not function as intended due to the potential for corrosion and/or failure of the internal spring which has been manufactured from an incorrect material. as an internal part of the instrument, the spring is not in direct contact with the patient. however, in the event that the spring or a subcomponent of the spring was to fail and/or corrode, the possibility exists that the particles may transfer from the instrument to the patient, potentially leading to an adverse tissue reaction and/or infection. a surgical delay may also arise if the retractor does not work during a procedure and a replacement needs to be found.To date, there have been no reports of adverse events related to this issue.
  • Acción
    Customers are asked to inspect invetory and to follow the instructions provided for any affected units. To mitigate risk, should customers with affected instruments require the instrument for emergency cases, please perform a visual and functional inspection, as detailed in the cistomer letter, prior to, during and after use. Customers are asked to exercise caution regarding the risk of corrosion or spring breaking during the procedure. This action has been closed-out on 04/04/2017.

Device

Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexible
  • Modelo / Serial
    Cheek Retractor, f/MatrixMANDIBLE U-shaped, flexiblePart Number: 397.232Multiple lot numbers affectedARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd