Events

Retiro De Equipo (Recall) de Mako THA Application User Guides

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-2017-RN-01129-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-29
  • 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-2017-RN-01129-1
  • 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
    Stryker has identified that the tha application user guides for specific item numbers did not have the risk control measure included. five risk control measure were not included in the specific tha application user guides:1. user guide warning to indicate risk of greater trochanter fracture due to insertion of screw.2. user manual instruct no to re-capture check-point without re-registration of bone.3. statement in the user guide to unscrew the impaction handle from the implant cup prior to freeing the rio arm.4. training and user guide will indicate insertion of femoral checkpoint may weaken great trochanter. 5. end effector (item number 205020) provides sufficient clearance to mitigate the risk of impingement. standard or technique to visually confirm that cuposition is correct.
  • Acción
    1. Inform users of this Recall for Product Correction and forward this notice to all those individuals who need to be aware within your organisation; 2. A Stryker representative will coordinate the swap out of the old version of the User Guides with the new version. The old version may continue to be used until the swap out has occurred; 3. Complete the supplied “Recall for Product Correction Notification Response” form upon receiving the letter to acknowledge you have seen it; and 4. Inform any recipients you may have transferred affected stock to.

Device

Mako THA Application User Guides
  • Modelo / Serial
    Mako THA Application User GuidesItem Numbers: 204863, 207116, 208692, 209711, 210555 and 212026All lots and versionsARTG Number: 223106
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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