Device Recall KyphX HVR Bone Cement

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0000776598, 0000790377, 0000790380, 0000794905, 0000794997, 0000794998, 0000794999, 0000795000, 0000802774, 0000802775, 0000819410, 0000825149, 0000828632, 0000828633, 0000841918, 0000841919, 0000842869, 0000842871, 0000848666, 0000848670, 0000858673, 0000892106, 000089859, 0000911555, 0000922990, 0000925894, 0000930458, 0000931993, 0000945996, 0000952887, 0000958800, 00009666732, 0000966734, 0000972324, 0000972325, 0000975787, 0000982884, 0000994176, 0001008470, 0001008472, 0001008598, 0001033988, 0001034877, 0001045184, 0001045187, 0001050788, 0001050789, 0001056101, 0001056102, 0001060659, 0001060662, 0001067884, 0001067886, 0001081545, 0001104034, 00841918, 88930458, J6092716, J6100426, J6101208, J6101808, J6103009, J6110310, J6110906, J6112008, J6112712, J6120108, J6121203, J6121902, J6121903, J6121904, J6121905, J6121906, J7010201, J7011107, J7011907, J7012506, J7020624, J7021509, J7022202, J7022702, J7030605, J7031401, J7031506, J7032310, J7032702, J7040213, J7041010, J7041301, J7042109, J7050101, J7050405, J7051107, J7051801, J7052511, J7060205, J7061130, J7062109, J7062708, J7070210, J7070706, J7071602, J7071906, J7072702, J7080702, J7081815, J7081816, J7082816, J7090620, J7091106, J7091208, J7091206, J7100606, J7101704, J7101705, J7110523, J7111216, J7111608, J7112823, J7120314, J7122101, J8010201, J8010402, J8010918, J8010718, J8041401, J8041705, J8042401, J8051203, J8051204, J8052915, J8052916, J8060205, J8060410, J8061208, J8010919, J8012214, J8013005, J8020117, J8020722, J8021910, J8030517, J8030518, J8031202, J8032601, J8040717, J8061209
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • 제품 설명
    Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. || Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Spine LLC, formerly Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: EL15106, EL15406, EL15706, EL16006, EL16406, EL16506, EL16806, EL17006, EL17307, EL17507, EL17607, EL17707, EL17807, EL18007, EL18307, EL18407, EL18707, EL18907, EL19207, EL19507, EL19807, EL20007, EL20107, EL20307, EL20407, EL20507, EL20607, EL20808, EL20908, EL21008, EL21208, EL21308, EL21608, EL21708, EL21908, EL22008, EL22108, EL22308, EL22908, EL23008, EL23508, EL23608, EL23708, EL24008, 24108, EL24208, EL24408, EL24508, EL24608, EL25008, EL25108, EL25408, EL25508, EL26409, EL26509
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • 제품 설명
    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. || Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
  • Manufacturer