Retiro De Equipo (Recall) de Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive (Battery-driven, cutting power tool system used in surgical procedures such as cutting of bone and hard tissue)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Johnson & johnson medical pty limited (jjm) has received reports that the oscillating saw attachment may disengage intra-operatively. if the device is tested in the operative theatre and the unit does not function, the user most likely would discontinue use of the affected part, and a replacement oscillating saw attachment would be procured, which may lead to surgical delay. injury to the patient can occur if the attachment disengages intra-operatively. there is also a potential of injury to the user from the sharp edge of the subject oscillating saw during retrieval. one report of a serious injury was received where the part fell apart during surgery and resulted in cuts in the hand of a user.
  • Acción
    Johnson & Johnson Medical Pty Limited (JJM) is providing instructions to customers for checking for any disassembly of the attachment as part of every reprocessing cycle. If customers notice any disassembly of the attachment or are able to unscrew the attachment as part of the inspection, they are advised to not use it and immediately send it for repair. Devices which perform satisfactorily during the inspection may be used as intended. A review and repair will be implemented if necessary during the next scheduled maintenance inspection at the Service Centre. Customers are also reminded to ensure the devices are sent for maintenance according to the recommended annual schedule.


  • Modelo / Serial
    Oscillating Saw Attachment for Colibri/Colibri II Small Electric Drive (Battery-driven, cutting power tool system used in surgical procedures such as cutting of bone and hard tissue)Part Number (Saw Attachment): 532.021All Serial NumbersProduct Numbers (Electric Drive): 532.001, 532.010, 532.101, 532.110 and 05.001.175ARTG number: 157072
  • Manufacturer