Devices

Device Recall Zimmer M/L Taper Hip Stem Standard & Extended Offset

  • 모델명 / 제조번호(시리얼번호)
    Product ID: 00771100500, Lot #: 60418073, 60814878, 61085493, 61221743, 61576204, 61621459, 61621460, 61801966, 61825644, 61825646, 61851938, 61856660, 61899990, 61909935, 61957246, 61963045, 61967714, 61978787, 62004470, 62071524, 62078280, 62101467, 62143024, 62145543, 62145545, 62179230, 62201751, 62207880, 62213705, 62219904, 62243355, 62309446, 62316375, 62323504, 62329221, 62329222, 62367889, 62386075, 62450636, 62458975, 62472170, 62547040, 62554175, 62564731, 62564732, 62571806, 62615699, 62645213, 62645214, 62652987, 62667687, 77000640 & 77002057.  Product ID: 00771100520, Lot #: 7886860, 60371589, 60389984, 60911201, 60993979, 60999893, 61112021, 61585384, 61622518, 61825666, 61825667, 61851924, 61904650, 61951060, 61967705, 62004472, 62004473, 62028785, 62107673, 62130149, 62135097, 62253657, 62253658, 62323506, 62335517, 62410994, 62458977, 62459364, 62472174, 62503201, 62547042, 62564734, 62571808, 62615703, 62636751 & 62636752.  Product ID: 00771100600, Lot #: 61067223, 61389192, 61440890, 61613526, 61699183, 61765877, 61772616, 61851919, 61870556, 61919457, 61925455, 61925460, 61978791, 61985997, 61998399, 62004516, 62016452, 62044968, 62125014, 62125015, 62125017, 62145557, 62184296, 62187413, 62213709, 62213710, 62219910, 62219911, 62226002, 62236538, 62323511, 62329225, 62329226, 62380990, 62416655, 62433042, 62459366, 62466091, 62489957, 62489958, 62529364, 62547046, 62554183, 62590697, 62615709, 62645219, 62652995, 62659348 & 77002100.  Product ID: 00771100620, Lot #: 7887710, 11006337, 60814885, 60837122, 60876619, 60935819, 61112024, 61304434, 61755954, 61784588, 61904652, 61945405, 61972436, 61998401, 62014575, 62016455, 62130154, 62153643, 62158627, 62201765, 62226004, 62249176, 62253663, 62274955, 62335527, 62356442, 62361541, 62361542, 62416667, 62423066, 62466094, 62489397, 62509251, 62540605, 62564743, 62571809, 62577958, 62586851, 62622688, 62622689 & 62653004.  Product ID: 00771100700, Lot #: 61734759, 61837544, 61978805, 62023873, 62059128, 62059132, 62078290, 62096904, 62101438, 62163749, 62169669, 62184307, 62184309, 62201774, 62201775, 62213721, 62226013, 62253668, 62253669, 62282222, 62295527, 62295529, 62302348, 62309461, 62316392, 62316393, 62316394, 62343052, 62350640, 62370012, 62379099, 62380993, 62380998, 62393286, 62393287, 62400751, 62433056, 62478042, 62478043, 62483286, 62484613, 62488308, 62488310, 62488314, 62521917, 62529381, 62540611, 62564748, 62586859, 62608633, 62615717, 62615720, 62630027, 62645229, 62645233, 62653011, 62653012, 62653018 & 62659363.  Product ID: 00771100720, Lot #: 60718307, 61329143, 61721071, 61791501, 61904659, 61915121, 61963043, 61978809, 61978811, 61998380, 62004524, 62053392, 62089239, 62089240, 62118159, 62150305, 62163761, 62198235, 62226017, 62231904, 62249178, 62271083, 62282231, 62289028, 62309538, 62316415, 62343058, 62445432, 62540618, 62548498, 62554198, 62571815, 62577960, 62577961, 62601229, 62608641, 62630036 & 62637054. Product ID: 00771100900, Lot #: 61239370, 61690526, 61874323, 61915128, 62004528, 62067023, 62089044, 62089241, 62107690, 62130175, 62135117, 62155221, 62184318, 62198246, 62207908, 62213747, 62213749, 62226020, 62226029, 62243384, 62258677, 62316423, 62323533, 62329246, 62329250, 62329251, 62329252, 62335549, 62350650, 62356461, 62361555, 62370030, 62370033, 62381019, 62386089, 62393301, 62393303, 62438941, 62444848, 62450646, 62452759, 62466109, 62478016, 62488334, 62488335, 62488336, 62489407, 62489414, 62489418, 62521935, 62529418, 62537946, 62547023, 62547026, 62550180, 62560190, 62568620, 62571824, 62571825, 62577965, 62577967, 62577978, 62577980, 62586867, 62590715, 62601238, 62608649, 62608653, 62630041, 62630044, 62636780, 62636785, 62653032, 62653040, 62665781, 62665786, 62665789 & 62667721. Product ID: 00771100920, Lot #: 61253985, 61375619, 61512772, 61585393, 61595710, 61957210, 61998409, 62041869, 62053407, 62067029, 62067030, 62078314, 62096919, 62114320, 62213762, 62226037, 62238364, 62243395, 62243396, 62243397, 62271102, 62309568, 62309570, 62309571, 62323544, 62343077, 62350658, 62356469, 62405422, 62478080, 62509279, 62515355, 62548501, 62550192, 62554218, 62571835, 62594217, 62601245, 62601246, 62608668, 62615738& 62636797. Product ID: 00771101000, Lot #: 61104476, 61365526, 61601704, 61904677, 62041873, 62101423, 62135135, 62141463, 62153669, 62163774, 62179304, 62191529, 62201817, 62213771, 62213774, 62219942, 62243404, 62323548, 62323553, 62323554, 62329274, 62335561, 62342732, 62343085, 62356476, 62356477, 62361572, 62370053, 62370054, 62381042, 62390757, 62405427, 62423111, 62433081, 62438955, 62438956, 62438959, 62452774, 62459016, 62459390, 62465786, 62466117, 62472217, 62484353, 62488357, 62488361, 62488362, 62489436, 62515359, 62515360, 62515361, 62521950, 62540635, 62540637, 62547083, 62550193, 62554223, 62554224, 62554227, 62554229, 62560013, 62564777, 62571840, 62594229, 62615741, 62630061, 62636814, 62645277, 62653052, 62659402, 62665815, 62667739, 62681734, 62681735 & 77002093. Product ID: 00771101020, Lot #: 61259321, 61622528, 61709486, 61784592, 61784593, 61784594, 61900027, 61966482, 61986040, 61998423, 62010415, 62071564, 62089271, 62118208, 62118210, 62145610, 62153681, 62243417, 62243418, 62253695, 62253698, 62265053, 62265055, 62282263, 62302393, 62309591, 62343088, 62350676, 62381050, 62400782, 62416737, 62423118, 62444860, 62445461, 62452781, 62478922, 62484355, 62489996, 62489997, 62515372, 62515373, 62547092, 62554235, 62564783, 62568626, 62594236, 62608688, 62615752, 62630069, 62630070 & 62630071. Product ID: 00771101100, Lot #: 61268897, 61397634, 61900032, 61945457, 61966419, 61992115, 62004546, 62014624, 62014628, 62053423, 62101433, 62114343, 62125039, 62125041, 62135146, 62179323, 62179326, 62198275, 62198276, 62201838, 62207928, 62213792, 62219957, 62246968, 62265060, 62275389, 62275393, 62282266, 62329285, 62329292, 62329294, 62350680, 62350682, 62361590, 62361594, 62370077, 62381077, 62381078, 62405441, 62411081, 62416741, 62416742, 62445470, 62450653, 62452787, 62457896, 62459027, 62466135, 62478022, 62489445, 62496194, 62515376, 62529440, 62540652, 62540653, 62560038, 62571850, 62571852, 62571855, 62578021, 62578023, 62608692, 62615756, 62615757, 62615760, 62622756, 62630077, 62636835, 62645298, 62645302, 62653074, 62653075, 62653076, 62659419, 62665830, 62667755, 62667758, 62667759 & 62681750. Product ID: 00771101120, Lot #: 61550131, 61574108, 61741520, 61812318, 61957205, 61986055, 61998379, 62042654, 62042655, 62089293, 62118226, 62118228, 62243431, 62243432, 62243433, 62246977, 62253712, 62271151, 62274971, 62289089, 62302421, 62302422, 62350689, 62367952, 62386127, 62386128, 62393357, 62393358, 62405456, 62449685, 62459038, 62466138, 62488383, 62496204, 62509307, 62540660, 62571873, 62571876, 62590744, 62622767, 62630086, 62630087, 62653088 & 62665848. Product ID: 00771101200, Lot #: 61239385, 61371703, 61729245, 61813502, 61837571, 61900043, 61925507, 61986064, 61992133, 62053440, 62096940, 62135171, 62153715, 62158688, 62163800, 62191554, 62226077, 62236570, 62238381, 62243440, 62246990, 62265069, 62275406, 62295570, 62316461, 62329304, 62329306, 62329308, 62361602, 62361603, 62361615, 62367955, 62381123, 62381127, 62386135, 62393365, 62393369, 62400796, 62433115, 62433118, 62445482, 62452797, 62459044, 62459405, 62484367, 62484368, 62484373, 62484605, 62484608, 62490022, 62496210, 62503259, 62515398, 62521974, 62540664, 62547111, 62554254, 62564803, 62571887, 62571888, 62571891, 62571892, 62571894, 62571895, 62578035, 62586925, 62594257, 62601289, 62601293, 62608711, 62622775, 62630096, 62645317, 62653098, 62659443, 62665854, 62667766, 62667767, 62667768, 62667770 & 62667773. Product ID: 00771101220, Lot #: 61684022, 61684027, 61792365, 61900048, 61951018, 62014651, 62014653, 62033982, 62033984, 62096947, 62096948, 62141489, 62179386, 62243451, 62243452, 62253735, 62274973, 62275409, 62275410, 62309633, 62335589, 62343112, 62343113, 62367968, 62370096, 62405483, 62411114, 62416762, 62445490, 62452805, 62472250, 62489469, 62490029, 62496221, 62521979, 62521982, 62554264, 62554266, 62560237, 62594272, 62594273, 62601298, 62601299, 62624984, 62653107 & 62665868. Product ID: 00771101300, Lot #: 60832119, 60837119, 61781476, 61910013, 61915163, 61945489, 62033922, 62033923, 62067065, 62085631, 62096953, 62101449, 62179397, 62184368, 62238385, 62243456, 62243458, 62275415, 62275417, 62289109, 62329318, 62329319, 62335595, 62342737, 62361622, 62367971, 62367972, 62370105, 62400816, 62405489, 62409718, 62411121, 62439010, 62439013, 62459056, 62466153, 62478037, 62478038, 62490033, 62496230, 62503267, 62540677, 62550210, 62554268, 62554269, 62554272, 62586943, 62586944, 62586950, 62594276, 62594278, 62608734, 62608736, 62615790, 62636872, 62636875, 62653117, 62653121, 62659457, 62659459, 62659460, 62665873, 62665879, 62667786, 62667788, 62681788 & 62681791.  Product ID: 00771101320, Lot #: 61271638, 61375629, 61626112, 61784607, 62010439, 62023916, 62163815, 62179415, 62184374, 62201868, 62226085, 62236571, 62243459, 62249191, 62275419, 62309647, 62316480, 62356539, 62381226, 62386154, 62416773, 62416774, 62427994, 62439017, 62472259, 62484382, 62484383, 62489479, 62489480, 62515430, 62540683, 62554275, 62564824, 62564825, 62564826, 62571923, 62594281, 62594282, 62594284, 62601314, 62615797, 62630117, 62653123 & 62659467.  Product ID: 00771101500, Lot #: 60663817, 61371715, 61631812, 61644835, 61825634, 61889909, 61910018, 61925521, 61998368, 62005258, 62067073, 62118255, 62153726, 62169808, 62169809, 62198304, 62231992, 62271178, 62271182, 62275422, 62302450, 62309652, 62329326, 62335599, 62335600, 62343123, 62350720, 62356545, 62367980, 62381243, 62393388, 62393390, 62405497, 62411150, 62416777, 62452825, 62457813, 62457946, 62472264, 62488409, 62488410, 62515434, 62515438, 62540687, 62578062, 62578063, 62586953, 62590762, 62601320, 62608741, 62622803, 62636881, 62653130, 62659472, 62665886 & 62667801.  Product ID: 00771101520, Lot #: 60697994, 60852321, 61067270, 61108714, 61468199, 61574112, 61576231, 61622536, 61791516, 61801913, 61894976, 61904711, 61986082, 61998444, 62022573, 62067528, 62071594, 62101463, 62114384, 62153728, 62226091, 62247023, 62271185, 62271186, 62282313, 62289115, 62295593, 62302455, 62350725, 62361630, 62367986, 62423163, 62459068, 62529451, 62540691, 62540692, 62540693, 62571929, 62571930, 62578065, 62586957, 62594293, 62630124, 62630125 & 62653134.  Product ID: 00771101600, Lot #: 61559496, 61559497, 61566491, 61595697, 61621514, 61679251, 61765957, 61860920, 61870584, 61951043, 61966461, 61972514, 62004576, 62023921, 62085098, 62089316, 62145634, 62165445, 62198310, 62219999, 62253761, 62253762, 62258730, 62295595, 62316483, 62329333, 62329334, 62335605, 62343130, 62361631, 62370117, 62383290, 62405503, 62416784, 62433153, 62439023, 62445507, 62489494, 62489495, 62496250, 62564837, 62586958, 62594294, 62594295, 62594296, 62601323, 62645341, 62665891 & 62667807.  Product ID: 00771101620, Lot #: 105548, 60384735, 61631832, 61673792, 61741538, 61765965, 61919554, 61963019, 61978880, 62010445, 62023923, 62085634, 62153731, 62163827, 62207976, 62247030, 62247031, 62253764, 62265084, 62295598, 62309659, 62329338, 62370120, 62393807, 62400823, 62428010, 62452833, 62521994, 62548508, 62564839, 62571934, 62578070, 62594298, 62601325, 62615807, 62622810, 62636887 & 61145719R.  Product ID: 00771101700, Lot #: 60400363, 60609658, 61440906, 61553101, 61553102, 61610075, 61610076, 61712743, 61825720, 61831226, 61870586, 61925530, 61941275, 61941277, 62010446, 62089319, 62130235, 62130237, 62145637, 62145640, 62201881, 62226094, 62253765, 62258732, 62265087, 62302461, 62312431, 62316485, 62329341, 62361633, 62433157, 62452834, 62452835, 62489497, 62564842, 62578071, 62601327, 62615809, 62622813, 62653143, 62653144, 62659485, 62665893 & 60460737R.  Product ID: 00771101720, Lot #: 60882289, 61171216, 61553140, 61553141, 61610031, 61690503, 61741528, 61805494, 61831190, 61978881, 61998451, 62004577, 62010447, 62078357, 62141505, 62179426, 62247035, 62253766, 62271191, 62302463, 62312432, 62323612, 62329344, 62343137, 62356553, 62367990, 62439025, 62445509, 62459413, 62489498, 62521997, 62540702, 62547135, 62564844, 62571936, 62578072, 62601328 & 62624988.  Product ID: 00771102000, Lot #: 60121420, 60369558, 60968999, 60993940, 61108748, 61559490, 61566487, 61930824, 61986087, 62179431, 62226096, 62329348, 62428017, 62466168, 62540703 & 62659489.  Product ID: 00771102020, Lot #: 60876607, 61054560, 61574113, 61791518, 61925533, 61963021, 61966522, 61978883, 62107738, 62184385, 62323616, 62329349, 62416791, 62554287 & 62615813.   Product ID: 00771102200, Lot #: 60180253, 60615468, 60852282, 60999884, 61085529, 61527309, 61527315, 61527321, 62243467, 62323618, 62329350, 62484390 & 62540705.  Product ID: 00771102220, Lot #: 102401, 60175884, 60199385, 60405478, 61098945, 61582026, 61963052, 62243470, 62323619, 62416792, 62586964, 60092140V, 60952630R & 61098945R.
  • 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 Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. 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