Events

Retiro De Equipo (Recall) de K-Wires for T2 and Gamma Systems (Internal fixation wire)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2016-RN-01469-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-10
  • 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-01469-1
  • 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
    Through a review of packaging, stryker has identified that the seal integrity of the pouch may be compromised. more specifically, there is a potential that the sterile pouch may not be sealed at one end due to a manufacturing error. a missing seal could potentially lead to unsterile product. risk mitigating factors include that the non-conformance is obvious to the user. surgical guidelines outline inspection of the sterile barrier (seal) for sterile packed medical devices prior to use. the pouch itself shows a note: “contents sterile unless this package has been damaged or opened.” the secondary packaging is a (plastic) clear tube with silicone caps at both ends. while not validated as a sterile barrier, it does provide additional protection to the enclosed pouch package configuration. no injury or harm has been reported regarding this issue.
  • Acción
    Customers are asked to inspect their inventory for affected products and quarantine any affected items immediately. A Stryker representative will coordinate the return of any affected product and supply unaffected ones where necessary. This action has been closed-out on 28/06/2017.

Device

K-Wires for T2 and Gamma Systems (Internal fixation wire)
  • Modelo / Serial
    K-Wires for T2 and Gamma Systems (Internal fixation wire) GAM Kirschner WireItem Number: 12106450ST2 K-WireItem Number: 18060050S T2 K-Wire ReconItem Number: 18063030S Multiple Lot Numbers affectedARTG Number: 143230
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA