Events

Retiro De Equipo (Recall) de Straumann dental surgical drills

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Straumann 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-01543-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-30
  • 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-01543-1
  • 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 investigation of a received complaint has confirmed that the shaft diameter of a drill article number 044.215 lot lv457 is greater than the defined specification of ø2.35mm in the area of the laser marking on the shaft. further investigation has shown that the further articles and lots are also impacted. testing with different handpieces shows that the drills can be inserted. however, depending on the manufacturing tolerances of the handpiece that is used, these drills may not fit. if the drills do not fit into the handpiece and there is not an alternative instrument available, then the the planned treatment would need to be re-scheduled.
  • Acción
    Straumann has advised customers to check their inventory for affected product and return all stock. Straumann will provide replacements. This action has been closed-out on 09/06/2017.

Device

Straumann dental surgical drills
  • Modelo / Serial
    Straumann dental surgical drillsDrill 1, short, Ø 2.2mm, l 33.0mm, SSArticle #: 044.210 Lot #: MG783Component # Number (on drill): LZ239Twist Drill PRO Ø4.2mm,long,41mm,SSArticle #: 044.255 Lot #: LV455Component Lot # (on drill): LF828 ARTG Number: 119314
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd