Events

Retiro De Equipo (Recall) de SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system)

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-01372-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-20
  • 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-01372-1
  • 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
    An issue has been identified where peel pouches for certain lot numbers of reaming rods are de-laminating. this may lead to surgical staff members experiencing difficulty in opening the peel pouches and potentially causing the sterile device to come in contact with a non-sterile layer of the pouch.In the event there is difficulty in opening the sterile peel pouch a surgical delay may occur while a replacement part is located or while re-sterilisation is performed. if surgery cannot be completed without the sterile part and no alternate is available, the procedure may need to be rescheduled. if there is delamination of the peel pouches the layering and fragments may compromise the sterility of the part, which may place the patient at risk for infection.
  • Acción
    Johnson & Johnson is advising customers to immediately quarantine affected product. Affected product may then be returned to Johnson & Johnson for replacement or unopened affected product may be re-sterilised per the product Sterilisation Instructions contained within the Instructions for Use provided with the product.

Device

SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the...
  • Modelo / Serial
    SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system)Part Number: 351.709SLot Numbers: 9913259, 9913260, 9963747, 9963748, 9963749, 9963751, 9963752, 9963753, 9963755, 9963756, 9963757, H040517, H040518, H060114, H060115, H060116, H080081, H080082, H080083, H080084, H080085, H080086, H080087, H080088, H080089, H105530ARTG Number: 15395
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes