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

Detalles del retiro

Fabricante

Zimmer Biomet, Inc.

Distribuidor

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.

Lote

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, 52171

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States