Events

Retiro De Equipo (Recall) de GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;

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 Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217.

¿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
    76988
  • Clase de Riesgo del Evento
    Unclassified Correction
  • Fecha de inicio del evento
    2017-03-28
  • Estado del evento
    Firm initiated action, Not yet classified 1
  • 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=154778
  • 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, Ac-Powered - Product Code GEY
  • Causa
    Diamond particulates may break off the burr and fall into the surgical site. if the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. these particulates could also lead to mechanically induced soft tissue damage.
  • Acción
    On April 7, 2017 8 Hospitals, 3 distributors and 11 sales reps were sent an Urgent Medical Device Recall Notification letter. Letters were sent UPS overnight. Customers were asked to immediately discontinue use and return the product to Aesculap, Inc.

Device

GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2....
  • Modelo / Serial
    Model numbers COARSE:  GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ;  Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    CA, IL, NY, PA, TN, TX
  • Descripción del producto
    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;
  • Manufacturer
    Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217

Manufacturer

Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217