Events

Retiro De Equipo (Recall) de MicroAire SmartRelease Endoscopic 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 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
    80095
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2107-2018
  • Fecha de inicio del evento
    2018-04-19
  • Fecha de publicación del evento
    2018-05-25
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164550
  • 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
    Arthroscope - Product Code HRX
  • Causa
    The instructions for use (ifu) is incorrect with regards to sterilization parameters and must be replaced.
  • Acción
    Urgent Medical Device Recall letters were distributed to customers. The letters instructed customers to do the following: If you have some quantity of IFUs remaining, we're asking you to destroy your current copies, IM-SMARTRELEASE Rev. A-D, and replace them by going on-line at MicroAire at www.microaire.com/resources. Click Carpal Tunnel, then SmartRelease Instruction Manual to obtain the latest version, IM-SMARTRELEASE Rev. E. Please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309. If you have no quantity of IFUs remaining, there are no further activities needed by you except for the mandatory returning of page two of this letter to notification@microaire.com or via fax at 800-648-4309. For further questions, please call (800) 722-0822.

Device

MicroAire SmartRelease Endoscopic System
  • Modelo / Serial
    All products distributed from 1/1/13 to 2/23/18
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of: Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, France, Germany, Hong Kong, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Mexico, Nicaragua, Poland, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, and UK.
  • Descripción del producto
    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D || The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
  • 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