{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81127",
      "recalling_firm": "Zimmer Biomet, Inc.",
      "address_1": "1800 W Center St",
      "address_2": "N/A",
      "postal_code": "46580-2304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country  of:  Australia.",
      "recall_number": "Z-0286-2019",
      "product_description": "EBI Osteogen Implantable Bone Growth Stimulator      The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.",
      "product_quantity": "4,879 units (2,982 units have been implanted and 537 have been scrapped)",
      "reason_for_recall": "Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.",
      "recall_initiation_date": "20180219",
      "center_classification_date": "20181101",
      "termination_date": "20200825",
      "report_date": "20181107",
      "code_info": "All serial numbers expiring prior to March 31, 2019 are affected.  Item # 10-1320 - OsteoGen 20/S;   Serial Numbers: 520798, 520841, 521079, 521260, 521446, 521886, 520830,   520795, 520789, 521881, 520705, 520799, 520842, 521080, 521261, 521447,   521887, 520831, 520796, 520793, 521875, 520706, 520800, 520843, 521081,  521262, 521448, 521888, 520832, 520797, 520837, 521439, 520708, 520801,   520844, 521082, 521263, 521449, 521889, 520833, 520839, 520838, 521440,   520709, 520802, 520845, 521083, 521264, 521862, 521890, 520834, 520840,  520884, 521253, 520710, 520803, 520846, 521084, 521265, 521863, 520717,  520875, 520886, 520885, 521254, 520711, 520804, 520867, 521086, 521267,  521864, 520718, 520876, 521078, 521255, 520881, 520712, 520805, 520868,  521087, 521268, 521865, 520719, 520878, 521257, 521256, 520882, 520713,  520806, 520869, 521089, 521269, 521866, 520720, 520879, 521259, 521442,  520835, 520714, 520827, 520871, 521090, 521321, 521867, 520721, 520880,  521444, 521443, 520836, 520715, 520828, 520872, 521091, 521322, 521868,   521883, 521873, 521445, 521882, 520787, 520716, 520829, 520873, 521092,  521323, 521869, 521872, 521874, 521884, 521885, 520788, 521094, 521250,   521251, 521093, 521324, 521870, 521871, 521325, 521326, 521437, 521438 and 521252.  Item # 10-1328S - OsteoGen - 20/SL;   Serial Numbers: 521246, 521367, 521374, 521381, 521388, 521495, 521537,  521387, 521493, 520912, 521247, 521368, 521375, 521382, 521389, 521496,  521538, 521373, 521535, 520913, 521248, 521369, 521376, 521383, 521390,  521497, 521539, 521380, 521492, 520914, 521249, 521370, 521377, 521384,  521490, 521498, 521245, 521366, 521386, 520915, 521364, 521371, 521378,  521385, 521491, 521499, 521536, 521244, 521379, 520916, 521365, and 521372  Item # 10-1320M - OsteoGen - 20/M;   Serial Numbers: 520857, 521020, 521284, 521597, 521723, 521934, 522046,  521990, 521932, 520722, 520858, 521021, 521285, 521598, 521724, 521935,  522047, 521991, 521933, 520723, 520859, 521022, 521286, 521599, 521725,  521936, 522048, 521996, 521589, 520724, 520860, 521023, 521287, 521600,  521727, 521937, 522049, 522003, 521590, 520725, 520861, 521024, 521288,  521601, 521728, 521939, 522050, 522004, 521715, 520726, 520862, 521025,  521289, 521602, 521729, 521940, 522051, 522005, 521716, 520727, 520863,  521027, 521296, 521603, 521730, 521941, 522052, 522006, 521926, 520728,  520864, 521030, 521297, 521604, 521731, 521942, 522053, 522007, 521927,  520729, 520865, 521031, 521298, 521605, 521732, 521943, 522054, 522008,  521283, 520730, 520866, 521032, 521299, 521606, 521733, 521944, 522055,  522009, 520847, 520731, 520887, 521033, 521300, 521607, 521734, 521945,  521587, 522010, 521010, 520732, 520888, 521034, 521301, 521608, 521735,  521946, 521165, 522011, 521170, 520733, 520889, 521035, 521302, 521609,  521736, 521947, 521166, 522012, 521588, 520734, 520890, 521036, 521303,   521610, 521737, 521948, 521167, 522013, 521714, 520735, 520891, 521037,  521304, 521611, 521738, 521949, 521168, 522014, 521925, 520736, 520892,  521038, 521305, 521612, 521739, 521950, 521169, 522015, 521282, 520737,  520893, 521039, 521306, 521613, 521740, 521951, 520974, 522036, 521277,  520738, 520894, 521115, 521307, 521614, 521741, 521952, 520975, 522037,  521276, 520739, 520895, 521116, 521308, 521615, 521763, 521953, 520976,  522038, 522121, 520740, 520896, 521117, 521309, 521616, 521764, 521954,  520977, 522039, 522124, 520741, 520897, 521118, 521310, 521617, 521765,   521955, 520979, 522040, 521591, 520742, 520898, 521120, 521311, 521618,  521766, 521956, 521585, 522041, 521592, 520743, 520899, 521121, 521312,  521619, 521767, 521957, 521899, 522042, 521593, 520744, 520900, 521123,  521313, 521620, 521785, 521958, 521924, 522043, 521594, 520745, 520901,  521125, 521314, 521621, 521786, 521959, 521709, 522044, 521595, 520746,  520902, 521126, 521315, 521622, 521787, 521960, 521710, 522045, 521596,  520747, 520903, 521127, 521397, 521624, 521788, 521961, 521711, 521928,   521717, 520748, 520904, 522128, 521398, 521625, 521789, 521962, 521712, 521929, 521718, 520749, 520905, 521129, 521399, 521626, 521790, 521963,  521713, 521930, 521719, 520750, 520906, 521130, 521400, 521627, 521791,  521964, 521583, 521931, 521720, 520751, 520927, 521131, 521403, 521628,  521792, 521965, 521584, 520820, 521721, 520752, 520928, 521132, 521405,  521629, 521793, 521968, 521856, 520821, 521722, 520753, 520929, 521133,  521406, 521630, 521794, 521969, 521857, 520822, 520848, 520754, 520930,  521134, 521408, 521631, 521795, 521970, ,521858, 520823, 520849, 520755,  520931, 521135, 521409, 521632, 521796, 521971, 521859, 520824, 521011,  520756, 520932, 521136, 521410, 521633, 521797, 521972, 521860, 520825,  521012, 520757, 520933, 521137, 521411, 521634, 521798, 521973, 521861,  520826, 521988, 520758, 520934, 521138, 521413, 521635, 521799, 521974,  521891, 521581, 521989, 520759, 520935, 521139, 521416, 521636, 521800,  521975, 521892, 521582, 520850, 520760, 520936, 521140, 521540, 521637,  521842, 521976, 521893, 521707, 520851, 520761, 520937, 521141, 521541,  521638, 521843, 521977, 521698, 521708, 520852, 520762, 520938, 521142,  521544, 521639, 521844, 521978, 521699, 521586, 520853, 520763, 520939,  521143, 521545, 521687, 521845, 521979, 521700, 521280, 520854, 520764,  520940, 521144, 521547, 521688, 521846, 521980, 521701, 521281, 520855,  520765, 520941, 521145, 521563, 521689, 521847, 521981, 521702, 520972,  520856, 520766, 520942, 521146, 521564, 521690, 521848, 521982, 521703,  520973, 521013, 520767, 520943, 521147, 521565, 521691, 521849, 521983,  521704, 521163, 521014, 520768, 520944, 521148, 521566, 521692, 521850,  521984, 521705, 521164, 521015, 520769, 520945, 521149, 521567, 521693,  521851, 521985, 521706, 521894, 521016, 520807, 520946, 521150, 521568,  521694, 521852, 521986, 521572, 521895, 521017, 520808, 520947, 521151,  521569, 521695, 521853, 521896, 521573, 521576, 521018, 520809, 520950,  521152, 521570, 521696, 521854, 521897, 521574, 521577, 521278, 520810,  520951, 521153, 521571, 521697, 521855, 521898, 521575, 521578, 521279,  520811, 520958, 521154, 521579, 520813, 520960, 521156, 520815, 520965,  521158, 520812, 520959, 521155, 521580, 520814, 520961, 521157, 520816,  520967, 521159, 520817, 520968, 521160, 520818, 520970, 521161, 520819,  520971, and 521162  Item # 10-1328M - OsteoGen - 20/ML;   Serial Numbers: , 520910, 521340, 521347, 521355, 521361, 521835, 521841,  521354, 521346, 520701, 520911, 521341, 521348, 521356, 521362, 521836,  520909, 521360, 521839, 520703, 521335, 521342, 521351, 521357, 521801,  521837, 520908, 521804, 521803, 520770, 521336, 521343, 521352, 521358,  521802, 521838, 521338, 521840, 521359, 520907, 521337, 521344 and   521353.  Item # 10-1318 - OsteoGen - 20/F;   Serial Numbers: 521463, 521467, 521471, 521475, 521479, 521514, 521878,   521877, 521474, 521460, 521464, 521468, 521472, 521476, 521510, 521462,  521879, 521513, 521470, 521461, 521465, 521469, 521473, 521477, 521512,  521876, 521880, 521478, and 521466  Item # 10-1348S - OsteoGen - 40/S;   Serial Numbers: 520675, 521049, 521233, 521481, 521502, 521516, 521525,  521678, 520673, 520663, 520676, 521050, 521234, 521482, 521503, 521517,  521526, 521679, 520674, 520664, 520677, 521051, 521235, 521483, 521504,  521518, 521527, 521680, 521500, 520665, 521040, 521052, 521236, 521484,  521505, 521519, 521528, 521681, 521501, 520666, 521041, 521053, 521237,  521485, 521506, 521520, 521529, 521682, 521242, 520667, 521042, 521054,  521238, 521486, 521507, 521521, 521530, 521683, 521243, 520668, 521043,  521055, 521239, 521487, 521508, 521522, 521531, 521684, 521058, 520669,  521044, 521056, 521240, 521488, 521509, 521523, 521532, 521685, 521059,  520670, 521045, 521057, 521241, 521489, 521515, 521524, 521533, 521686,   521480, 520671,521046, 520672, 521047, 521048, and 521232.  Item # 10-1322S - ,OsteoGen - 40/SL;  Serial Numbers: 521114, 521223, 521230, 521776, 521784, 521783, 521818,  521113, 521229, 521000, 521217, 521224, 521231, 521777, 521334, 521782,  521819, 521824, 521222, 521001, 521218, 521225, 521331, 521778, 521221,  521228, 521820, 521817, 521112, 521002, 521219, 521226, 521332, 521780,  521004, 521822, 521821, 521815, 521775, 521003, 521220, 521227, 521333,  521781, 521816, and 521823.  Item # 10-1348M - OsteoGen - 40/M;  Serial Numbers: 520918, 521062, 521177, 521209, 521645, 521676, 521833,  520784, 520917, 520678, 520919, 521063, 521178, 521210, 521646, 521677,  521834, 520785, 520999, 520679, 520920, 521064, 521179, 521212, 521647,  521742, 521900, 520786, 521060, 520680, 520921, 521065, 521180, 521213,  521648, 521743, 521901, 520781, 521061, 520681, 520922, 521066, 521181,  521215, 521649, 521744, 521902, 520782, 521174, 520682, 520923, 521067,  521182, 521216, 521650, 521745, 521903, 520783, 521175, 520683, 520924,  521068, 521183, 521417, 521651, 521746, 521904, 520996, 521176, 520684,  520925, 521069, 521184, 521418, 521652, 521747, 521905, 520997, 521205,  520685, 520926, 521095, 521185, 521419, 521653, 521748, 521906, 520998,  521206, 520686, 520980, 521096, 521186, 521420, 521654, 521749, 521907,  521171, 521208, 520687, 520981, 521097, 521187, 521421, 521655, 521750,  521908, 521172, 521642, 520688, 520982, 521098, 521188, 521422, 521656,  521751, 521909, 521202, 521643, 520689, 520983, 521099, 521189, 521423,  521657, 521752, 521910, 521203, 521644, 520690, 520984, 521100, 521190,  521424, 521658, 521753, 521911, 521436, 521673, 520691, 520985, 521101,  521191, 521425, 521659, 521754, 521912, 521640, 521674, 520692, 520986,  521102, 521192, 521426, 521660, 521755, 521913, 521670, 521675, 520772,  520987, 521103, 521193, 521427, 521661, 521756, 521914, 521671, 521830,  520773, 520988, 521104, 521194, 521428, 521662, 521757, 521826, 521827,   521831, 520774, 520989, 521105, 521195, 521429, 521663, 521758, 521669,  521828, 521832, 520775, 520990, 521106, 521196, 521430, 521664, 521759,  521201, 521435, 521829, 520776, 520991, 521107, 521197, 521431, 521665,  521760, 520995, 521111, 521672, 520777, 520992, 521108, 521198, 521432,  521666, 521761, 520780, 521173, 521641, 520778, 520993, 521109, 521199,  521433, 521667, 521762, 521668, 521825, 521204, 520779, 520994, 521110,  521200, and 521434.    and  Item # 10-1322M - OsteoGen - 40/ML.  Serial Numbers: 521009, 521327, 521452, 521552, 521771, 521923, 521006,  521007, 521920, 520693, 521070, 521328, 521453, 521553, 521772, 522031,  521396, 521008, 521921, 520694, 521071, 521329, 521454, 521554, 521773,  522032, 521293, 521295, 521561, 520695, 521072, 521330, 521455, 521555,  521774, 522033, 521005, 521451, 521562, 520696, 521073, 521391, 521456,  521556, 521915, 522034, 521919, 521551, 521549, 520697, 521074, 521392,  521457, 521557, 521916, 522035, 521560, 521770, 521550, 520698, 521290,  521393, 521458, 521558, 521917, 521294, 521548, 521922, 521450, 520699,  521291, 521394, 521459, 521559, 521918, 520700, 521292, and 521395."
    }
  ]
}