FDA Enforcement Class I Terminated

EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.

Recall: Z-0286-2019 · Reported November 7, 2018

Enforcement

Recall Number: Z-0286-2019
Event ID: 81127
Classification: Class I
Status: Terminated
Product Type: Devices
Firm: Zimmer Biomet, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: November 7, 2018
Initiation Date: February 19, 2018
Classification Date: November 1, 2018
Termination Date: August 25, 2020
Address: 1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

Description

Reason

Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

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.

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.

Quantity

4,879 units (2,982 units have been implanted and 537 have been scrapped)