Events

Retiro De Equipo (Recall) de Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw)

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
    Recall
  • ID del evento
    RC-2016-RN-00979-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-22
  • 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-2016-RN-00979-1
  • 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
    It was identified that the specified lots of the locking screws stardrive ø 2.4 mm, self-tapping, length 12 mm, tan can break between the head and the shaft. this resulted from the neck feature being too close to the stardrive feature leaving a thin wall between the neck and drive. in the event that the non-conforming screw should separate between the head and the shaft during insertion or removal, a surgical delay may occur as the surgeon attempts to remove the shaft or fragment from the bone. removal of fragments can result in bone damage. additionally, a protruding fragment can lead to adverse tissue reaction or soft tissue irritation.
  • Acción
    Johnson &Johnson; Medical (JJM) is advising customers to identify, quarantine and return all unpackaged Locking Screws Stardrive Ø 2.4 mm, self-tapping, length12 mm, TAN in kits along with any screws still in the original packaging with the affected part and lot number. JJM Customer Service will organise replacement products for the returned stock

Device

Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orth...
  • Modelo / Serial
    Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw)Part Number: 412.812Lot Numbers: 9744302, 9946065Supplied as part of following systems: LCP Distal Radius System 2.4LCP Compact Hand 2.4LCP Compact Foot 2.42.4/2.7 mm Locking Tarsal PlatesARTG number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes