Z-0286-2019 Class I Terminated
FDA device recall Z-0286-2019 was initiated by Zimmer Biomet, Inc. on Feb 19, 2018 and is designated Class I. Reason for recall: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. The recall status is terminated (terminated Aug 25, 2020). Affected quantity: 4,879 units (2,982 units have been implanted and 537 have been scrapped).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- Feb 19, 2018
- Termination Date
- Aug 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,879 units (2,982 units have been implanted and 537 have been scrapped)
Product Description
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Reason for Recall
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0286-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026