Events

Retiro De Equipo (Recall) de ELAN 4

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.

¿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
    79068
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0621-2018
  • Fecha de inicio del evento
    2017-09-05
  • 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=161272
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Causa
    Elan 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
  • Acción
    Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.

Device

ELAN 4
  • Modelo / Serial
    All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to 4 hospitals in the following states: NM, OH, TX, WV
  • Descripción del producto
    ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 || ELAN 4 1-RING NEURO CUTTER SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER D2.0 || ELAN 4 1-RING NEURO CUTTER D2.5 || ELAN 4 1-RING NEURO CUTTER D3.0 || ELAN 4 1-RING NEURO CUTTER TC D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 || ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG || ELAN 4 2-RING NEURO CUTTER SOFT D2,0 || ELAN 4 2-RING NEURO CUTTER SOFT D2,5 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER TC D3,0 || ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 || ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 || ELAN 4 2-RING DIAMOND DISC || ELAN 4 2-RING SIDE CUTTER TC D3,0 || SAW BLADE S sagittal 11/13/0,3 || SAW BLADE S sagittal 15/5/0,3 || SAW BLADE S sagittal 20/5/0,3 || SAW BLADE S sagittal 20/10/0,3 || SAW BLADE S sagittal 20/15/0,3 || SAW BLADE S sagittal 25/5/0,3 || SAW BLADE S sagittal 25/12/0,3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || ELAN 4 1-RING NEURO CUTTER D1.5+ || ELAN 4 1-RING NEURO CUTTER D2.0+ || ELAN 4 1-RING NEURO CUTTER D2.5+ || ELAN 4 1-RING NEURO CUTTER D3.0+ || ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 || ELAN 4 1-RING NEURO PRECISE D1.5 || ELAN 4 1-RING NEURO PRECISE D2.0 || ELAN 4 1-RING NEURO PRECISE D2.5 || ELAN 4 1-RING NEURO PRECISE D3.0 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Dirección del fabricante
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA