Devices

Device Recall Ossur Total Knee

  • Model / 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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
  • 1 Event

Manufacturer

Ossur North America Inc
  • Manufacturer Address
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall Ossur Total Knee
  • Model / Serial
    Serial numbers: 5787 ¿ 6207 including the following repaired units outside the stated range. 5339, 5471, 5478, 5670.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total Knee
  • Model / 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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total Knee
  • Model / Serial
    Serial numbers: 6918 ¿ 7569
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total knee
  • Model / 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
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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