Events

Retiro De Equipo (Recall) de Device Recall InFast Ultra Transvaginal Bladder Neck Support System

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 American Medical Systems.

¿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
    46833
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1235-2008
  • Fecha de inicio del evento
    2008-01-28
  • Fecha de publicación del evento
    2008-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68313
  • 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
    Fastener, Fixation, Nondegradable, Soft Tissue - Product Code MBI
  • Causa
    Missing part: the units in two lots of in-fast ultra transvaginal bladder neck support system may contain only one bone screw, but should contain two as indicated on the labeling. two screws are required to complete the procedure. the missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.
  • Acción
    All customers received phone calls on 1/28/08 explaining the error and associated risks and were followed up with detailed letters. The letter "AMS Important Product Recall" dated 1/28/08 described the product and problem. Customers were advised to return the enclosed "Recall Acknowledgement Form" to AMS along with any affected product that they have in inventory.

Device

Device Recall InFast Ultra Transvaginal Bladder Neck Support System
  • Modelo / Serial
    Lot Numbers: 527059 and 527061.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • Dirección del fabricante
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA