Devices

Device Recall Zimmer M/L Taper Reduced Neck Standard & Extended Offset,

  • 모델명 / 제조번호(시리얼번호)
    Product ID: 00771100410, Lot #: 60876583, 61098988, 61158127, 61230791, 61542496, 61548105, 61702995, 61729254, 61904645, 61957233, 61963047, 61998392, 62004467, 62067479, 62078278, 62096889, 62107667, 62145541, 62153634, 62184289, 62246880, 62246881, 62253651, 62265027, 62283066, 62316369, 62343031, 62356431, 62361531, 62380986, 62390746, 62445410, 62459360, 62472165, 62495527, 62528301, 62529331, 62529334, 62529335, 62529341, 62577926, 62577929 & 62630007.  Product ID: 00771100440, Lot #: 60500974, 60597171, 60824961, 61040634, 61510553, 61601757, 61703092, 61796656, 61870553, 61880423, 61904646, 61963030, 61967702, 62101479, 62135089, 62153635, 62158616, 62176234, 62179221, 62202469, 62239214, 62253653, 62253654, 62275332, 62275333, 62302332, 62309445, 62316374, 62342712, 62405371, 62410988, 62472168, 62521896, 62554173, 62571801, 62577931, 62601210 & 62645212.  Product ID: 00771100510, Lot #: 61098989, 61158128, 61595675, 61734799, 61791458, 61870554, 61919455, 61967734, 61985992, 62023864, 62059114, 62085023, 62135094, 62135095, 62143027, 62145548, 62145549, 62145551, 62169649, 62198214, 62238349, 62243359, 62243360, 62302339, 62302341, 62342714, 62367890, 62445414, 62458976, 62459363, 62509237, 62529278, 62529353, 62529362, 62537985, 62540589 & 62554177.  Product ID: 00771100540, Lot #: 60659250, 61030264, 61085549, 61098994, 61595699, 61690452, 61749176, 61765962, 61796657, 61845539, 61865602, 61966525, 62004475, 62078283, 62096893, 62130151, 62143029, 62153639, 62158620, 62207884, 62258663, 62271060, 62275338, 62323507, 62335521, 62335522, 62361538, 62445416, 62452735, 62489955, 62503202, 62540593, 62594190 & 62615704.  Product ID: 00771100610, Lot #: 61030252, 61416334, 61523437, 61894915, 61894916, 61966499, 62085032, 62114298, 62158626, 62207887, 62219914, 62226003, 62236540, 62238352, 62243369, 62243372, 62243373, 62275343, 62289018, 62302344, 62309453, 62335525, 62356440, 62379097, 62393282, 62405381, 62409688, 62410998, 62411003, 62423064, 62423065, 62445419, 62452741, 62478872, 62478874, 62488298, 62503204, 62528348, 62528349, 62529374, 62529375, 62529377, 62529379, 62550187, 62560161, 62577945, 62615711, 62659356 & 62665753.  Product ID: 00771100640, Lot #: 60474089, 60663859, 60911091, 61158157, 61553126, 61631840, 61741531, 61851980, 61860883, 61966531, 62023869, 62059125, 62143033, 62153641, 62187415, 62198221, 62219917, 62219918, 62246894, 62246895, 62265031, 62274956, 62275347, 62343049, 62379098, 62393285, 62405385, 62445421, 62503207, 62521909, 62571810 & 62615713.  Product ID: 00771100710, Lot #: 60771280, 61273016, 61499266, 61734803, 61784581, 61812353, 61851927, 62014580, 62053391, 62078295, 62118155, 62141440, 62158635, 62201777, 62231894, 62231895, 62231898, 62243374, 62243375, 62243378, 62275356, 62282228, 62295531, 62302353, 62309465, 62335540, 62343056, 62367904, 62370016, 62381004, 62381005, 62393291, 62400759, 62405394, 62411014, 62416694, 62423075, 62452751, 62458992, 62458994, 62472190, 62488317, 62488318, 62509254, 62509255, 62528381, 62529406, 62537934, 62540614, 62547061, 62547063, 62560179, 62615729, 62645241, 62659370, 62665772, 62681694 & 62681696.  Product ID: 00771100740, Lot #: 61550135, 61631841, 61734866, 61772718, 61801919, 61972446, 62023879, 62023881, 62096907, 62135115, 62141445, 62184314, 62198237, 62207901, 62226018, 62231906, 62236548, 62253676, 62289036, 62289037, 62295537, 62309552, 62329235, 62335546, 62343068, 62381009, 62381010, 62393296, 62411019, 62416699, 62416703, 62423083, 62433065, 62433067, 62450644, 62484310, 62488330, 62496123, 62503221, 62540619, 62548499, 62586864, 62594206, 62615732, 62645247, 62645248, 62653028 & 62665780.  Product ID: 00771100910, Lot #: 61487760, 61734804, 61851922, 61919486, 61930771, 62004532, 62028813, 62085052, 62114319, 62191514, 62231919, 62243388, 62249182, 62265046, 62295542, 62295546, 62302368, 62316429, 62343075, 62350653, 62350654, 62370035, 62381023, 62405415, 62411029, 62423093, 62433074, 62438948, 62457810.62457930, 62488343, 62489427, 62509268, 62528392, 62540628, 62540631, 62547073, 62547074, 62554217, 62560009, 62560195, 62577987, 62594212, 62601242, 62608666, 62645268, 62645269 & 62667726.  Product ID: 00771100940, Lot #: 61626141, 61805446, 61865594, 62044986, 62135133, 62158651, 62179284, 62226041, 62231939, 62236554, 62246930, 62246931, 62253686, 62253687, 62271105, 62271107, 62295547, 62302374, 62316432, 62323546, 62356470, 62361568, 62379104, 62393315, 62393316, 62400772, 62411062, 62416723, 62416724, 62416726, 62484342, 62489432, 62489984, 62540634, 62554221, 62560204, 62577989, 62590723, 62594226, 62601247, 62608671, 62615739, 62622732, 62645275, 62653046 & 62667736.  Product ID: 00771101010, Lot #: 61074843, 61468181, 61755935, 61801882, 62010413, 62107715, 62114333, 62118203, 62236555, 62238371, 62243413, 62243415, 62275380, 62302387, 62316440, 62329279, 62329280, 62350671, 62350673, 62367934, 62393333, 62409705, 62433087, 62433088, 62459020, 62488365, 62496183, 62496185, 62503233, 62515365, 62515366, 62521956, 62529433, 62529437, 62537950, 62560211, 62560212, 62578001, 62578010, 62586893, 62601260, 62622743, 62630063, 62630066, 62645288, 62645289, 62645290, 62662266, 62665820 & 62665822.  Product ID: 00771101040, Lot #: 61772722, 61831167, 61851965, 61967716, 62053420, 62063891, 62114337, 62130198, 62130199, 62153683, 62179308, 62198270, 62201832, 62213783, 62246952, 62246953, 62253699, 62271119, 62289076, 62323563, 62343090, 62386116, 62393343, 62423122, 62427973, 62433096, 62433097, 62438975, 62490004, 62490005, 62496188, 62521960, 62550199, 62601265, 62608690, 62622749 & 62645296.  Product ID: 00771101110, Lot #: 61510528, 61644836, 61825649, 62014630, 62023896, 62053432, 62089285, 62107718, 62118221, 62130209, 62153694, 62153695, 62169771, 62179331, 62179334, 62231959, 62243427, 62246973, 62275394, 62275395, 62275396, 62282276, 62289085, 62302411, 62309605, 62335576, 62367948, 62381101, 62405446, 62409728, 62445474, 62452544, 62459035, 62466136, 62478927, 62537961, 2594247, 62601276, 62615767, 62630082, 62636841, 62645306, 62653080 & 62667760.  Product ID: 00771101140, Lot #: 11003867, 60697997, 61280663, 61298526, 61482862, 61601719, 61814634, 61874350, 61978850, 62096935, 62130212, 62153699, 62201846, 62219967, 62246984, 62258705, 62275399, 62289094, 62316457, 62328717, 62343103, 62370087, 62381110, 62393361, 62416752, 62427976, 62427978, 62452790, 62452791, 62472240, 62478931, 62488385, 62489453, 62489454, 62554247, 62578034, 62594255, 62608710 & 62653089.  Product ID: 00771101210, Lot #: 61178805, 61613564, 62023912, 62059189, 62085092, 62101443, 62107720, 62107722, 62118239, 62176269, 62179379, 62179381, 62207950, 62243442, 62243443, 62243445, 62243446, 62253732, 62258711, 62302435, 62309625, 62350699, 62356523, 62370093, 62381159, 62381161, 62405478, 62416759, 62427980, 62433120, 62433121, 62466147, 62472247, 62515406, 62528411, 62540672, 62547114, 62560235, 62560236, 62571906, 62578052, 62586930, 62590752, 62601294, 62608723, 62608724, 62608726, 62630099, 62645322, 62645325, 62653104 & 62665865.  Product ID: 00771101240, Lot #: 60911093, 61712776, 61831168, 61930803, 61930804, 61963039, 61966512, 62053451, 62114366, 62135178, 62135179, 62141490, 62201861, 62231982, 62247002, 62249190, 62258714, 62258715, 62271166, 62271167, 62289105, 62316472, 62350706, 62367969, 62381181, 62400811, 62416764, 62416765, 62433134, 62433135, 62459054, 62465797, 62472252, 62515416, 62515417, 62521983, 62571916, 62608731, 62630108, 62653113 & 62653114.
  • 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 Reduced Neck Standard & Extended Offset, 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.
  • 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