Devices

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

  • Modelo / Serial
    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.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
  • Descripción del producto
    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

Fabricante

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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