Reported Nov 7, 2018 · Terminated
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the…
Zimmer Biomet, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
- Lot codes and dates
- All serial numbers expiring prior to March 31, 2019 are affected. Item # 10-1320 - OsteoGen 20/S
- Serial Numbers520798, 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
521246521367521374521381521388521495521537521387521493520912521247521368521375521382521389521496521538521373521535520913521248521369521376521383521390521497521539521380521492520914521249521370521377521384521490521498521245521366521386520915521364521371521378521385521491521499521536521244521379520916521365and 521372 Item # 10-1320M - OsteoGen - 20/M
- Serial Numbers520857, 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 Numbers520910, 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
521463521467521471521475521479521514521878521877521474521460521464521468521472521476521510521462521879521513521470521461521465521469521473521477521512521876521880521478and 521466 Item # 10-1348S - OsteoGen - 40/S
- Serial Numbers
96 of 96 codes
520675521049521233521481521502521516521525521678520673520663520676521050521234521482521503521517521526521679520674520664520677521051521235521483521504521518521527521680521500520665521040521052521236521484521505521519521528521681521501520666521041521053521237521485521506521520521529521682521242520667521042521054521238521486521507521521521530521683521243520668
- Serial Numbers521114, 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 Numbers520918, 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
78 of 78 codes
521009521327521452521552521771521923521006521007521920520693521070521328521453521553521772522031521396521008521921520694521071521329521454521554521773522032521293521295521561520695521072521330521455521555521774522033521005521451521562520696521073521391521456521556521915522034521919521551521549520697521074521392521457521557521916522035521560521770521550520698
- Amount recalled
- 4,879 units (2,982 units have been implanted and 537 have been scrapped)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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