Devices

Device Recall Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology

  • 모델명 / 제조번호(시리얼번호)
    Product:  00771300500 Lots:  63006851 63006852 63024180 Product: 00771300600 Lots: 63024183 63024184 63024186 63024187 63024188 63024189 Product: 00771300700 Lots: 63024193 63024195 63024196 63024197 63024198 63024199 63024201 63024202 63024203 63024204 63024205 63024206 Product: 00771300900 Lots: 62927082 62927083 63024210 63024211 63024213 63024214 63024215 63024216 63024217 63024218 63024219 63024220 63024221 Product: 00771301000 Lots: 62938997 63024226 63024227 63024228 63024229 63024230 Product: 00771301100 Lots: 62885040 62905574 62998426 63024234 63024235 63024236 63024237 63024238 63024239 63024240 63024241 Product: 00771301200 Lots: 62927123 63024256 63024257 63024258 63024259 63024261 63024262 63024263 Product: 00771301300 Lots: 62885058 62939008 63024245 Product: 00784801400 Lot: 62924878 Product: 65771301100 Lot: 62939041
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, WI and countries of Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy.
  • 제품 설명
    M/L Taper with Kinectiv¿ Technology. || prosthesis, hip, semi-constrained (metal uncemented acetabular component) || Product Usage: Usage: || Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

제조사

Zimmer, Inc.
  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

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Device Recall Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology
  • 모델명 / 제조번호(시리얼번호)
    Product ID: 00771300500, Lot #: 61694618, 61743290, 61812682, 61845568, 61845569, 61972395, 61972396, 61978915, 62030113, 62044919, 62118875, 62134957, 62163650, 62169474, 62225879, 62225880, 62354721, 62418036, 62418040, 62460390, 62478289, 62586736 & 62687940.  Product ID: 00771300600, Lot #: 60958672, 61468347, 61768416, 61945209, 62071403, 62179055, 62198165, 62238299, 62243210, 62361446, 62422692, 62425093, 62425097, 62430583, 62460385, 62478293, 62484262, 62528055, 62554084, 62616549, 62667448, 62681512 & 77002699.  Product ID: 00771300700, Lot #: 61856468, 61950857, 61985935, 62118858, 62153527, 62163657, 62247195, 62275860, 62361448, 62361449, 62414878, 62414882, 62418044, 62454089, 62454091, 62454093, 62489358, 62521396, 62528063, 62554092, 62578361, 62614850, 62652926, 62659300 & 62681516.  Product ID: 00771300900, Lot #: 61548886, 62225891, 62282073, 62335405, 62335409, 62356148, 62361455, 62367790, 62414880, 62417690, 62472139, 62484266, 62489363, 62496069, 62521565, 62530628, 62540514, 62554103, 62564692, 62578368, 62578370, 62652933, 62667455 & 62700933.  Product ID: 00771301000, Lot #: 61356738, 61796994, 61850999, 62030070, 62124949, 62169497, 62198185, 62253484, 62288848, 62342743, 62342963, 62342967, 62367798, 62367799, 62443121, 62443123, 62503161, 62560129, 62564694, 62564698, 62578377, 62594161, 62652941, 62652942, 62667463, 62694065 & 77003232.  Product ID: 00771301100, Lot #: 61576325, 61786474, 61909829, 61950874, 62066981, 62163668, 62201722, 62207778, 62253492, 62417698, 62428479, 62432955, 62432959, 62450085, 62496079, 62521571, 62521572, 62540529, 62554121, 62564702, 62578385, 62616557, 62647175, 62647178, 62659302, 62667466 & 62667469.  Product ID: 00771301200, Lot #: 60898841, 61300903, 61409710, 62030078, 62041818, 62163670, 62198191, 62207784, 62253638, 62270938, 62282101, 62356206, 62418052, 62428484, 62428488, 62432966, 62478323, 62484283, 62496086, 62503168, 62521407, 62546967, 62546968, 62546975, 62564705, 62578401, 62659306 & 62687964.  Product ID: 00771301300, Lot #: 61542773, 61909835, 61978950, 61998346, 62030103, 62059101, 62066988, 62176190, 62213560, 62219796, 62243241, 62350591, 62418054, 62420827, 62425109, 62484286, 62489381, 62521416, 62521419, 62578404, 62614869, 62622958 & 62681546.  Product ID: 00771301500, Lot #: 61613909, 61743314, 61894833, 61925319, 61967638, 62014552, 62014553, 62071435, 62130041, 62213563, 62225910, 62253643, 62350594, 62361478, 62420834, 62594177, 62622960 & 62652963.  Product ID: 00771301600, Lot #: 60803338, 61735132, 61781830, 61796999, 61837511, 61945229, 61945232, 61966387, 61991587, 62030114, 62041829, 62114219, 62153556, 62246579, 62420836, 62432974, 62432975, 62432976 & 77002653.  Product ID: 00771301700, Lot #: 11002955, 60815998, 60819830, 60845838, 61719863, 61741697, 61894835, 62010559, 62078152, 62101365, 62124961, 62207790, 62219802, 62253646, 62361479, 62478333, 62521429, 62564713, 62578411 & 60841248R.  Product ID: 00771302000, Lot #: 60617023, 60940201, 61326522, 61576337, 61613958, 61729730, 61985982, 62078154, 62225912, 62295421, 62356231 & 62478335.  Product ID: 00771302200, Lot #: 11001594, 11001595, 11001596, 11003622, 60617024, 60837142, 60940196, 61040881, 61081253 & 62342976.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
  • 제품 설명
    Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. || The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
  • Manufacturer
    Zimmer, Inc.