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U.S. Department of Health and Human Services

Class 1 Device Recall EBI Osteogen Implantable Bone Growth Stimulator

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  Class 1 Device Recall EBI Osteogen Implantable Bone Growth Stimulator see related information
Date Initiated by Firm February 19, 2018
Create Date November 02, 2018
Recall Status1 Open3, Classified
Recall Number Z-0286-2019
Recall Event ID 81127
PMA Number P790005 
Product Classification Stimulator, invasive bone growth - Product Code LOE
Product EBI Osteogen Implantable Bone Growth Stimulator

The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
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. 
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 2/22/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 4,879 units (2,982 units have been implanted and 537 have been scrapped)
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LOE and Original Applicant = EBI, LLC
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