Devices

Device Recall Ossur Total Knee

  • Modelo / Serial
    Serial numbers: 5787 ¿ 6207 including the following repaired units outside the stated range. 5339, 5471, 5478, 5670.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Descripción del producto
    Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.
  • Manufacturer
    Ossur North America Inc
  • 1 Event

Fabricante

Ossur North America Inc
  • Dirección del fabricante
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA

4 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Ossur Total Knee
  • Modelo / Serial
    Serial numbers: 14466 ¿ 16053 including the following repaired units outside the stated range. 12588, 13131, 13216, 13236, 13265, 13363, 13487, 13573, 13598, 13799, 13967, 14028, 14032, 14127, 14143, 14158, 14159, 14370.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Descripción del producto
    Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total Knee
  • Modelo / Serial
    Serial numbers: 38198 ¿ 40858 including the following repaired units outside the stated range. 18989,19232, 27029, 27804, 28629, 28923, 30538, 31033, 31104, 31108, 31110, 31111, 31113, 32040, 32229, 32293, 32352, 32528, 32556, 32704, 32712, 32849, 33016, 33035, 33038, 33435, 33626, 33644, 33770, 33963, 34025, 34032, 34131, 34205, 34257, 34331, 34362, 34448, 34544, 34562, 34578, 34631, 34753, 34756, 34783, 34870, 34926, 34994, 35125, 35257, 35328, 35412, 35755, 35810, 35819, 35845, 35969, 35981, 36157, 36209, 36391, 36636, 36665, 36733, 36871, 36902, 36955, 36960, 37098, 37114, 37128, 37147, 37172, 37243, 37255, 37291, 37310, 37554, 37625, 37717, 37788, 37910, 37987, 38047, 38197.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Descripción del producto
    Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total Knee
  • Modelo / Serial
    Serial numbers: 6918 ¿ 7569
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Descripción del producto
    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
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