Events

Alerta De Seguridad O Notificaciones De Seguridad para DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por DePuy CMW.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2007/081
  • Número del evento
    CON2032850
  • Fecha
    2007-10-25
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032850
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Recall of smartseal™ pressuriser as the outer pouch seal may be compromised. depuy cmw is recalling smartseal™ pressurisers used during cemented total hip joint replacement surgery, because the outer peelable pouch seals may be creased and therefore may not be intact. the inner peelable pouch seals are intact and therefore the device is likely to remain sterile. depuy cmw is recalling this product as a precautionary measure. the manufacturer is currently investigating the root cause of the packaging problem. the mhra is not aware of any incidents associated with these affected devices. the manufacturer estimates that about 15,000 potentially affected devices have been distributed in the uk since april 2005. the manufacturer wrote to users about this recall in july 2007 (see mhra website). however, only 5% of the affected devices had been returned to the manufacturer by 04 october 2007. this notice is intended to facilitate the manufacturer’s recall.
  • Acción
    Identify and quarantine affected devices. Do not use affected devices. Return affected devices to the manufacturer.

Device

DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack)
  • Modelo / Serial
  • Descripción del producto
    Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW. DePuy SmartSeal™ pressuriser: femoral and acetabular pressurisers (5 pack)  for use with orthopaedic bone cement. Part numbers 3206045 – 45mm acetabular pressuriser 3206052 – 52mm acetabular pressuriser 3206055 – 55mm acetabular pressuriser 3206060 – 60mm acetabular pressuriser 3206065 – 65mm acetabular pressuriser 3206002 – wedge femoral pressuriser 3206005 – standard femoral pressuriser Lot numbers - all lot numbers are affected by this recall. Any DePuy SmartSeal pressurisers that have a black tick on the bottom right hand corner of the pouch and on the carton have already been re-inspected by DePuy CMW and the manufacturer has verified that the seals are fully intact. These products are now excluded from the recall.
  • Manufacturer
    DePuy CMW

Manufacturer

DePuy CMW