Events

Retiro De Equipo (Recall) de Device Recall ChordX Chordal Sizer

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 On-X Life Technologies, Inc..

¿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
    75951
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1057-2017
  • Fecha de inicio del evento
    2016-12-13
  • Fecha de publicación del evento
    2017-01-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151822
  • 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
    Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replac - Product Code PAW
  • Causa
    Four issues were uncovered by the recalling firm's capa: 1) burrs were found to be present on left housing, right housing and barrel components, 2) loose plastic particulate was found within sealed primary packages, 3) loose hair was discovered within four sealed primary packages and 4) assembly error, wherein left and right housing components were acceptably press-fit together, was discovered within one sealed primary package. one of the left housing press-fit pins was not pressed into the associated hole of the right housing, resulting in a small gap in the housing assembly.
  • Acción
    A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.

Device

Device Recall ChordX Chordal Sizer
  • Modelo / Serial
    72-00-47420
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    CA, WA, NE, DE, OH, ME, TX
  • Descripción del producto
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
  • Manufacturer
    On-X Life Technologies, Inc.

Manufacturer

On-X Life Technologies, Inc.
  • Dirección del fabricante
    On-X Life Technologies, Inc., 1300 E Anderson Ln Ste B, Austin TX 78752-1739
  • Source
    USFDA