Events

Retiro De Equipo (Recall) de Device Recall STERIS Fine Traction Device

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Steris Corporation.

¿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
    65573
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1786-2013
  • Fecha de inicio del evento
    2013-05-20
  • Fecha de publicación del evento
    2013-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119612
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Apparatus, traction, non-powered - Product Code HST
  • Causa
    A bearing used in the assembly of the fine traction device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. the change order authorized use of the substitute bushing in assembly of the fine traction accessory; however, inadvertently the new part was not implemented. during complaint evaluati.
  • Acción
    STERIS Account Managers notified affected customers via onsite visits. All consignees were notified as of 5/29/2013. Customers were instructed to return affected product for a replacement unit.

Device

Device Recall STERIS Fine Traction Device
  • Modelo / Serial
    The following serial/lot numbers are affected by this recall:  0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
  • Descripción del producto
    STERIS Fine Traction Device, one unit per box || Product Usage: || The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Empresa matriz del fabricante (2017)
    Steris Corporation
  • Source
    USFDA