Events

Retiro De Equipo (Recall) de GemLock Long Hex Driver

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer 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-2015-RN-00146-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-23
  • 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-2015-RN-00146-1
  • 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 dental identified that certain lots of the gemlock long hex driver, catalogue rhl2.5, may not fit into the fixture mount transfer (fmt) or the internal hex of the implant. the affected product was also distributed within the tapered swissplus & swissplus implant systems kit, surgical, complete, catalogue opcst as well as the tapered screw-vent implant system surgical kit, complete, catalogue tsvkit.
  • Acción
    Zimmer is requesting their customers to quarantine the affected units. A Zimmer distributor will arrange for the removal of affected products. This action has been closed-out on 4/08/2016.

Device

GemLock Long Hex Driver
  • Modelo / Serial
    GemLock Long Hex Driver Catalogue Number: TSVKITLot Number on Label: 62702589*Etched Lot Number of RHL2.5: 62699693* Not all drivers used to assemble this kit lot are affected, as multiple lots of the driver were used to manufacture the kits. Drivers etched with lot 62632712, which function appropriately. Lot Number on Label: 62743075Etched Lot Number of RHL2.5: 62735177ARTG number: 126570
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer 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