Events

Retiro De Equipo (Recall) de JTS Drive Unit

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-2017-RN-00865-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-19
  • 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-00865-1
  • 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
    Stryker has received three complaints regarding the jts drive unit. these relate to the potential for utilisation of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device and the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.New labelling is to be provided, and a quick start guide attached to the device, along with revisions to the limb lengthening protocol & operation manual to reference these labelling modifications. these modifications/ updates are to clarify the correct orientation in relation to the limb entry point of the device.
  • Acción
    Stryker is requesting: 1. Users of this Medical Device forward the supplied notice to all those individuals who need to be aware within their organisation; 2. Inspect inventory for the impacted JTS Drive Unit and quarantine it immediately; 3. Contact their local Stryker representative to coordinate the return of any affected product you may have; 4. Complete the supplied “Medical Device Recall Notification Response” form even if they do not have any affected product. Return the form to Stryker by fax on (02) 9467 1325 or electronically via email to recalls@stryker.com; 5. If any affected stock could have been transferred from their hospital to another location, please immediately let them know of this recall and notify Stryker 6. If customers have disposed of any affected units, provide the item and lot numbers of the disposed product to Stryker via email account recalls@stryker.com.

Device

JTS Drive Unit

Manufacturer

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