Retiro De Equipo (Recall) de Verso Shoulder Forked Retractor (Comprehensive Instrumentation (2 Prong Retractor))

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 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • 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
    An investigation has identified that verso shoulder forked retractor part number 402582 was manufactured using 420 stainless instead of 420 s29 stainless steel. 420 stainless steel is more brittle than 420 s29. the instrument may fracture during use. if the retractor fractures during surgery, surgical intervention may be necessary to retrieve any fractured pieces. a delay in surgery greater than 30 minutes may occur. if the pieces are unable to be retrieved, the patient would retain a foreign body.
  • Acción
    The sponsor is advising users to inspect stocks and quarantine the affected units. The sponsor will remove and replace the affected units. This action has been closed-out on 25/01/2017.


  • Modelo / Serial
    Verso Shoulder Forked Retractor (Comprehensive Instrumentation (2 Prong Retractor))Part number: 402852All Lots affectedARTG Number: 177811
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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