Events

Retiro De Equipo (Recall) de Drill set long, drill stop compatible for D 4.8mm

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-2014-RN-01212-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-10
  • 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-01212-1
  • 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
    Institut straumann has received a customer complaint reporting that 040.447s drill set long, drill stop compatible for d 4.8mm implant lot gy037 contains a green colour coded drill which is incorrectly d3.5mm instead of d4.2mm. the investigation of this complaint has confirmed that the green colour coded drill is only d3.5mm. all other drills within the set 040.477s drill set long, drill stop compatible for d 4.8mm implant are correct. the investigation determined that there are potentially two further drill sets 040.447s that contain an incorrect drill (d3.5mm / green colour coding) and that these drills sets are in one of the listed lot numbers. this issue is limited to article number 040.447s lot numbers gy037, ha443, he874, hl216 only.This action was undertaken prior to the notification to the tga.
  • Acción
    Straumann Australia requested the customers to check their inventory and if the article 040.447S Drill set long, drill stop compatible for D 4.8mm Implant Lot HA443 is still in your inventory, please return it to Straumann Australia for credit or replacement. This action was undertaken prior to the notification to the TGA.

Device

Drill set long, drill stop compatible for D 4.8mm
  • Modelo / Serial
    Drill set long, drill stop compatible for D 4.8mm Implant Article number: 040.447S Lot numbers: GY037, HA443, HE874, HL216
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd