Events

Retiro De Equipo (Recall) de CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)

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-2016-RN-00484-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-22
  • 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-2016-RN-00484-1
  • 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 pivot cinchlock ss knotless anchor is a non-degradable implant device intended for the fixation of soft tissue to bone.Several complaints have been received relating to the pull wire breaking. there are two modes of failure identified for the pull wire; near the inserter handle and at the most distal tip where the wire ends with a larger diameter tip.The broken pull wire may spring out of the inserter handle that may injure the user. inserter components may break or disassemble leading to minor surgical delay to remove fragments or fragments left in bone after the procedure.
  • Acción
    Stryker is advising users to inspect and quarantine any of the affected items. Affected stock can be returned to Stryker for replacement with unaffected stock. This action has been closed out 01 Feb 2017

Device

CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)
  • Modelo / Serial
    CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)Catalogue Number: CAT02462Lot Numbers: 15120801, 15121401, 16010402, 16011901, 16012501ARTG Number: 229717
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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