Events

Retiro De Equipo (Recall) de RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomet 3i 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-2017-RN-01320-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-01
  • 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-01320-1
  • 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
    Zimmer biomet has identified that the 2.5mm gemlock hex driver, rhd2.5 contained within a surgical kit may contain a manufacturing anomaly affecting the geometry of the driver’s hex feature, which prevents it from properly engaging with mating components. the rhd2.5 hex driver is used to carry and drive the implant into the osteotomy by connecting to the fixture mount/transfer or directly to the implant. two instruments, rh2.5 and rh2.5l, may be utilised as alternatives to the rhd2.5.
  • Acción
    Zimmer Biomet is advising customers to review their inventory and return affected drivers. Please note that this recall is specific to the hex driver and as such there is no need to return entire surgical kit. Zimmer Biomet will provide replacement RHD2.5 hex drivers to affected customers upon return of affected RHD2.5 hex drivers. Two instruments, RH2.5 and RHL2.5 may be utilised as alternatives to the RHD2.5.

Device

RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit
  • Modelo / Serial
    RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical KitSurgical KitItem Number: TSVKITLot Number: 63666560UDI Number: (01)00889024019614(10)63666560ARTG Number: 126570 (Biomet 3i Australia Pty Ltd - Dental implant suprastructure device, temporary)
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA