Events

Retiro De Equipo (Recall) de Total Knee

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 Ossur H / F.

¿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
    53127
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0965-2012
  • Fecha de inicio del evento
    2009-08-10
  • Fecha de publicación del evento
    2012-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84735
  • 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
    Joint, knee, external limb component - Product Code ISY
  • Causa
    Some units of the total knee junior produced between november 25th, 2008 and through april, 2009 contain balancing units that may fail under extreme use over a long period. the fault is noncritical and no incidents or injuries resulting from this situation have been reported to ossur at this stage. over long term use (estimated to be in the four to six year range) the prosthetic device may fail a.
  • Acción
    Ossur sent a Safety Notice dated August 10, 2009 by mailed to all affected consignees. Ossur informed consignees of the above mentioned public reason for recall and asked consignees to take the following action: Identify the users of each of the Total Knee Junior model devices listed above and check inventory and isolate any recalled devices on hand but have not fitted on users. The letter states that Sue Fitzgerald from customer service will be contacting consignees in the next few days to coordinate replacement of the affected devices. For question call 1-(800) 219-2150, Ext: 4109. In addition, Ossur website: www.ossur.com we will be posting updates as appropriate.

Device

Total Knee
  • Modelo / Serial
    Serial Numbers: 8573, 8574, 8575, 8577, 8578, 8580, 8581, 8582, 8583, 8584, 8585, 8586, 8587, 8588, 8589, 8599, 8600, 8602, 8603, 8604, 8605, 8606, 8609, 8610, 8611, 8613, 8616, 8620, 8621, 8622, 8624, 8628, 8629, 8630, 8631, 8632, 8633, 8634, 8635, 8636, 8638, 8639, 8640, 8642, 8643, 8644, 8645, 8646, 8666, 8670, 8671, 8672, 8673, 8674, 8675, 8678, 8679, 8680, 8682, 8684, 8685, 8687, 8688, 8691, 8692, 8693, 8694, 8695, 8696, 8697, 8698, 8699, 8701, 8715, 8716, 8717, 8719, 8720, 8722, 8723, 8725, 8739, 8755, 8756, 8757, 8758, 8759, 8760, 8761, 8784, 8787.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) in the state of: AL, AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, and WV and the countries of: Australia, Canada, China, France, Germany, Hong Kong, Israel, Japan, Malaysia, Netherlands, New Zealand, Portugal, Puerto Rico, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, United Kingdom and United States.
  • Descripción del producto
    Total Knee Junior Model Number 1100 || Product Usage: || The Total Knee¿ Junior is an external polycentric prosthetic knee with a geometric locking system.
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Dirección del fabricante
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA