Events

Retiro De Equipo (Recall) de Device Recall MicroAire Pneumatic Impactor

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 MicroAire Surgical Instruments, LLC.

¿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
    73661
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1834-2016
  • Fecha de inicio del evento
    2016-03-11
  • Fecha de publicación del evento
    2016-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144676
  • 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
    Motor, surgical instrument, pneumatic powered - Product Code GET
  • Causa
    Microaire discovered that 20 suspect impactor instruments ( microaire pneumatic impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
  • Acción
    MicroAire sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you please respond to this letter promptly to determine how many of these units you have and will be returning to MicroAire. Upon return of the instrument to MicroAire, MicroAire will provide you with replacements. Please complete and send back to MicroAire page two of this letter, indicating that you do have this instrument at your facility and whether you will be returning the instrument for replacement. You can email the form to MicroAire Customer Service at notification@microaire.com or fax the form to 1-800-648-4309. You can contact MicroAire Customer Service at 1-800-722-0822 in the United States or 1-434-975-8000 outside the United States, between the hours of 8:30 AM and 5:30 PM (ET) Monday through Friday if you have any questions.

Device

Device Recall MicroAire Pneumatic Impactor
  • Modelo / Serial
    2500-100 Ser#s 1547,1546,1545,1544, 1543,1542, 1541,1540,1539,1538,1537,1536,1535,1534,1533,1532  2500-200 Ser#s 1464,1463,1462,1461
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    United States
  • Descripción del producto
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector || Professional Use, Medical Industry
  • Manufacturer
    MicroAire Surgical Instruments, LLC

Manufacturer

MicroAire Surgical Instruments, LLC
  • Dirección del fabricante
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9006
  • Empresa matriz del fabricante (2017)
    Colson Associates Inc.
  • Source
    USFDA