Events

Retiro De Equipo (Recall) de CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and/or bone fragments)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Wright Medical 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-00914-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-27
  • 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-00914-1
  • 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
    As an outcome of an investigation from a field complaint, wright medical discovered that certain claw and claw ii plates were manufactured from an incorrect raw material. the raw material specified for claw and claw ii plates is stainless steel meeting the requirements of astm f139 in a cold worked condition, however the material used meets the requirements of astm f139 stainless steel, but is in an annealed condition, which has reduced strength and increased ductility.
  • Acción
    Wright Medical is recalling affected stock from hospitals. Additionally, Wright Medical is advising surgeons that if the intended postoperative instructions are followed by the patient, the product will still perform as intended. If the patient does not follow instructions and bears weight on the plate prior to fusion the ductility of the material may increase the likelihood of malunion or non-union. Prophylactic revision surgery is not recommended. For more details, please see http://www.tga.gov.au/safety/alerts-device-claw-plates-140829.htm . This action has been closed-out on 16/05/2017.

Device

CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and...
  • Modelo / Serial
    CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and/or bone fragments)CLAW 3.5MM PLATE 2 HOLE 30MM (40130130);CLAW PLATE 20MM INTERAXIS (40S20020);CLAW II 2 HOLE 15MM (40240215), 20MM (40240220), 25MM (40240225), 30MM (40240230);CLAW II STRAIGHT20 X 20MM (40242020), 20 X 25MM (40242025), 25 X 25MM (40242525). (Catalog Numbers in brackets)Multiple lot numbers affectedARTG Number: 198485
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd