Events

Retiro De Equipo (Recall) de Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placement of soft tissue grafts during ligament reconstructive surgery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-01035-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-08
  • 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-01035-1
  • 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
    Several batches of whipknot soft tissue cinch #5 sutures have a potential packaging issue. a smith & nephew internal evaluation revealed that the packaging design is insufficient to prevent a potential sterile barrier breach (pin hole) in the tyvek film of the pouch.If the sterile barrier breach is not detected prior to use, the compromised packaging could potentially lead to a non-sterile device entering the surgical field.To date, there have been no complaints or adverse events associated with this issue.
  • Acción
    Smith & Nephew is advising users to immediately locate and quarantine affected devices. Affected stock will be replaced with unaffected product.

Device

Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placeme...
  • Modelo / Serial
    Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placement of soft tissue grafts during ligament reconstructive surgery)Product number: 7211015Multiple batch numbers affectedARTG number: 99843
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd