Events

Retiro De Equipo (Recall) de GENESIS II TIBIAL DRILL GUIDE

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 Smith & Nephew Inc.

¿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
    55673
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1900-2010
  • Fecha de inicio del evento
    2010-04-20
  • Fecha de publicación del evento
    2010-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91516
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Causa
    Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side.
  • Acción
    All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.

Device

GENESIS II TIBIAL DRILL GUIDE
  • Modelo / Serial
    Batch # 08JM07761 and 08JM07761A.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.
  • Descripción del producto
    GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA || Drill guide used as manual surgical instrument during knee replacement surgeries.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Dirección del fabricante
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA