Events

Retiro De Equipo (Recall) de Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD

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
    72719
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0584-2016
  • Fecha de inicio del evento
    2015-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142027
  • 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
    Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
  • Causa
    The 16 devices distributed in the united states were incorrectly labeled as the monoblock birmingham hip modular head, with labeling not cleared for marketing in the us. the actual devices were monoblock modular femoral head for hemiarthroplasty use.
  • Acción
    The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial notice

Device

Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD
  • Modelo / Serial
    All codes
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution. US nationwide, France, UAE, Austria, Australia, Belgium, CANADA, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, ISRAEL, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, PORTUGAL, Sweden, SINGAPORE, Thailand, Turkey, and SOUTH AFRICA.
  • Descripción del producto
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: || 74121238, MODULAR HEAD 38 MM -8MM || 74121242, MODULAR HEAD 42 MM -8MM || 74121246, MODULAR HEAD 46 MM -8MM || 74121250, MODULAR HEAD 50 MM -8MM || 74121254, MODULAR HEAD 54 MM -8MM || 74121258, MODULAR HEAD 58 MM -8MM || 74121338, MODULAR HEAD 3 8MM -4 (SHORT) || 74121342, MODULAR HEAD 42 MM -4 (SHORT) || 74121346, MODULAR HEAD 46 MM -4 (SHORT) || 74121350, MODULAR HEAD 50 MM -4 (SHORT) || 74121354, MODULAR HEAD 54 MM -4 (SHORT) || 74121358, MODULAR HEAD 58 MM -4 (SHORT) || 74121438, MODULAR HEAD 38 MM +0 (MED) || 74121442, MODULAR HEAD 42 MM +0 (MED) || 74121446, MODULAR HEAD 46 MM +0 (MED) || 74121450, MODULAR HEAD 50 MM +0 (MED) || 74121454, MODULAR HEAD 54 MM +0 (MED) || 74121458, MODULAR HEAD 58 MM +0 (MED) || 74121538, MODULAR HEAD 38 MM +4 (LONG) || 74121542, MODULAR HEAD 42 MM +4 (LONG) || 74121546, MODULAR HEAD 46 MM +4 (LONG) || 74121550, MODULAR HEAD 50 MM +4 (LONG) || 74121554, MODULAR HEAD 54 MM +4 (LONG) || 74121558, MODULAR HEAD 58 MM +4 (LONG)
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Dirección del fabricante
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA