Events

Retiro De Equipo (Recall) de Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short Attachments

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-00040-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-22
  • 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-2014-RN-00040-1
  • 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
    Laser marking location is out of specification (i.E., greater than 2.00 inches from the distal end of the cutting burr). fracture of the carbide cutting bur could occur if short cutting burrs with an out of specification laser location were used with an attachment that may have worn bearings. cutter fracture could result in user laceration, re-operation due to remaining fragments, soft tissue damage due to fragment retrieval, and delay in surgery.
  • Acción
    Synthes is advising users to return affected units.

Device

Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with ...
  • Modelo / Serial
    Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short AttachmentsPart Number: S-15DRMCMultiple lot numbers affectedARTG Number: 141597
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd