Events

Retiro De Equipo (Recall) de Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)

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-01468-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-09
  • 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-01468-1
  • 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 reports of two potential issues related to the offset cup reamer handle. the weld on the u-joint of the handle may become damaged over time, potentially causing the pin or pieces of the pin to fall into the wound. if that occurs, and the surgery proceeds with reaming, the pin or pieces of the pin may fall into the wound, which may be removed if visible or may be left in the wound. the handle also may not fully engage with the registration array and/or reamer basket. if that occurs, the surgery may proceed using a backup offset reamer handle, a straight reamer handle or manual instrumentation.
  • Acción
    Customers are advised to inspect their inventory for affected product and quarantine it immediately. A Stryker representative will coordinate the return of any affected products. This action has been closed-out on 28/06/2017.

Device

Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Ace...
  • Modelo / Serial
    Offset Cup Reamer Handle(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)Item Number: 207080All Lot Numbers affectedContained within trays: 151550, 151550-TARTG Number: 223107
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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