Events

Retiro De Equipo (Recall) de Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer flex Gen.1- 3.14.251 Reaming shaft flex. Gen.1- 3.15.252 Countersink reamer flex. Gen.2- 3.14.256 Reaming shaft flex. 46-52 Gen.2- 3.14.257 Reaming shaft flex. 54-64 Gen.2- 3.14.258 Reaming shaft flex. 60-68 Gen.2- 3.14.259 Shaft flex. Gen.1- 3.40.501 Countersink reamer flex. Gen.3- 55.02.1901 Reaming shaft flex. Gen.3- 55.02.1903 seleXys Shaft flex- 5502.00.2 Shaft flex- 3.14.545

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mathys Orthopaedics 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-00794-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-29
  • 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-00794-1
  • 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 validated process for the flexible shaft provides directions for a combined manual and mechanical cleaning/disinfection procedure. if the mandatory manual process as described in the processing instruction cannot be ensured/ performed, instruments by mathys ltd with flexible shafts may not be used. mathys ltd received feedback from hospitals that although the guidelines for processing and sterilising instruments were followed, residues on the instrument were still found. therefore mathys has developed an update to the processing instructions for the concerned instruments.
  • Acción
    Mathys is notifying end users of the validated method for cleaning/disinfection of flexible shafts.

Device

Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer fl...
  • Modelo / Serial
    Surgical Instruments with flexible shaftsDescription & ArticleRM Classic Countersink reamer flex Gen.1- 3.14.251Reaming shaft flex. Gen.1- 3.15.252Countersink reamer flex. Gen.2- 3.14.256Reaming shaft flex. 46-52 Gen.2- 3.14.257Reaming shaft flex. 54-64 Gen.2- 3.14.258Reaming shaft flex. 60-68 Gen.2- 3.14.259Shaft flex. Gen.1- 3.40.501Countersink reamer flex. Gen.3- 55.02.1901Reaming shaft flex. Gen.3- 55.02.1903seleXys Shaft flex- 5502.00.2Shaft flex- 3.14.545
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd