Events

Retiro De Equipo (Recall) de Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tornier 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-00971-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-18
  • 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-00971-1
  • 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
    Complaints have been received which describe a non-optimum grip of tibial inserts with the tibial impactor salto talaris which could lead to the fall of the implant. tornier's investigations have led to the conclusion that only sizes 0 and 1 of the tibial implant are not sufficiently maintained by the tibial impactor which, however, remains functional.
  • Acción
    Tornier advised their customers that even if the impactor does not ensure optimal holding of sizes 0 and 1 only of the tibial implant, it can still safely be usedand requested that care be taken when using the device for implantation of sizes 0 and 1 of the tibial implants. Tornier is redesigning the device and will notify customers once complete.

Device

Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talar...
  • Modelo / Serial
    Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)Serial Numbers: 30, 152ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd