Devices

Device Recall Ossur Total Knee

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
  • 1 Event

제조사

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

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Device Recall Ossur Total Knee
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 5787 ¿ 6207 including the following repaired units outside the stated range. 5339, 5471, 5478, 5670.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total Knee
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total Knee
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 6918 ¿ 7569
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc
Device Recall Ossur Total knee
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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