EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer Biomet, Inc.
- Reason for Recall:
- Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0286-2019
Related Recalls
Device has the potential for fracture during use.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.