Events

Retiro De Equipo (Recall) de Device Recall Ossur 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 Engineering, 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
    58002
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1822-2011
  • Fecha de inicio del evento
    2011-02-11
  • Fecha de publicación del evento
    2011-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97954
  • 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 - Product Code ISY
  • Causa
    The recall was initiated based on a finding by ossur that some units of the total knee 2100 produced from october 19th, 2010 until january 21st 2011, contained back links that may compromise knee function prematurely.
  • Acción
    Ossur initiated a Safety Notice (Voluntary Product Recall) letter on February 11, 2011, via US Postal Service Registered Mail. The recall letter informed the affected customers of the reason for the recall and the product affected. Ossur requested their distributor and providers take the following action: (1) Please identify the users of each of the Total Knee 2100 model devices listed above; (2) Also, please check your inventory and isolate any recalled devices you have on hand but have not fitted on users. Customers were also informed that a representative from Ossur customer service will be contacting them to coordinate replacement of the affected devices. The letters were followed by phone calls placed by a trained Ossur Customer Service Representative to each customer after US distributors provided Ossur with customer contact information. For questions regarding this recall call 517-629-8890.

Device

Device Recall Ossur Total knee
  • Modelo / Serial
    Serial Numbers (new units):13241, 13243, 13245, 13246, 13247, 13248, 13251, 13252, 13253, 13254, 13255, 13256, 13259, 13260, 13261, 13262, 13263, 13264, 13265, 13266, 13267, 13268, 13269, 13270, 13271, 13272, 13282, 13284, 13285, 13286, 13287, 13289, 13290, 13293, 13296, 13297, 13298, 13300, 13301, 13302, 13304, 13306, 13307, 13308, 13309, 13310, 13311, 13312, 13313, 13314, 13315, 13317, 13318, 13319, 13320, 13321, 13322, 13323, 13324, 13325, 13326, 13327, 13329, 13330, 13331, 13332, 13333, 13334, 13335, 13336, 13337, 13338, 13339, 13340, 13341, 13342, 13344, 13345, 13346, 13347, 13348, 13349, 13350, 13351, 13352, 13353, 13354, 13358, 13360, 13363, 13364, 13365, 13368, 13369, 13370, 13371, 13372, 13373, 13374, 13375, 13376, 13377, 13378, 13379, 13380, 13381, 13384, 13385, 13386, 13387, 13393, 13394, 13395, 13397, 13399, 13400, 13401, 13407, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13420, 13431  Repairs units: 9611, 10325, 10616, 11615, 11747, 11795, 12091, 12092, 12097, 12098, 12101, 12104
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CA, CO, FL, LA, MD, MI, MO, NJ, NY, OH, TN, VA,, and WA and the countries of Australia, Canada, Czech Republic, Germany, France, United Kingdom, Ireland, Italy, Japan, The Netherlands, Russian Federation, Sweden and Turkey.
  • Descripción del producto
    Ossur Total Knee, Model Number: 2100 || The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads.
  • Manufacturer
    Ossur Engineering, Inc

Manufacturer

Ossur Engineering, Inc
  • Dirección del fabricante
    Ossur Engineering, Inc, 910 Burstein Dr, Albion MI 49224-4011
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA