Events

Retiro De Equipo (Recall) de Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Signature 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-2017-RN-01413-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-11-15
  • 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-01413-1
  • 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
    Signature orthopaedics is recalling the affected batches of the logical 20 degree hooded xlpe liner. the batch numbers are displayed on the product labels. these devices are not intended for the market in australia, and had been distributed following a logistical error.There is no risk to patient safety as a result of this issue.
  • Acción
    Signature Orthopaedics is advising users to inspect stock and quarantine any remaining units from the affected batches. There is no additional safety risks or follow up required for implanted devices.

Device

Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabula...
  • Modelo / Serial
    Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component) Catalogue Numbers: 111-12-0250, 111-12-0660, 111-12-0652, 111-12-0656Batch Numbers: 77FAE, 78320, 78347, 7739B, 78334, 7739C-1ARTG Number: 277875 (Signature Orthopaedics Pty Ltd - Logical XLPE Liner - Non-constrained polyethylene acetabular liner)
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd