Class 3 Device Recall Conserve Shells

• Date Initiated by Firm: June 21, 2016
• Date Posted: December 01, 2016
• Recall Status: Terminated on July 01, 2017
• Recall Number: Z-0687-2017
• Recall Event ID: 75063
• 510(K)Number: K100866
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664; For use with the conserve metal head
• Code Information: REF 38021146 Serial Numbers: 02210174, 09217496, 01333507, 02334561, 03336229, 04338462, 05340904, 05341951, 10349882, 11351847, 04460698, 04460243, 06480454, 07488190 REF 38021148 Serial Numbers: 02210175, 05216035, 11228750, 01334562, 02336230, 03338463, 05340563, 05340911, 05341952, 09349879, 10352999, 10352998, 10351848, 01457244, 04460700, 04460699, 06481575, 07488019 REF 38021150 Serial Numbers: 01210176, 02210612, 04216036, 05216626, 07218586, 10230051, 03338616, 03338464, 03336231, 03337220, 05340564, 05340914, 05341953, 09349877, 10353000, 10351849, 12353001, 03460701, 04461613, 04461614, 07487904, 059819773 REF 38021152 Serial Numbers: 01210171, 03210614, 09216037, 11232599, 01334560, 01334563, 03336232, 03337221, 03338465, 05340915, 05341909, 06341954, 07348270, 08348659, 09349871, 09349872, 10351850, 11353002, 11353003, 11355254, 02458854, 03469912, 03469913, 06480452, 07485576, 07487905, 104109633, 09496818, 11496825, 059819775, 059821148 REF 38021154 Serial Numbers: 01210177, 02210611, 02211334, 06218587, 07216038, 07221034, 07222228, 10228749, 12232600, 01334564, 02335957, 02336233, 02337222, 03338466, 04339246, 05340565, 05340916, 07343890, 07341955, 08348653, 09348652, 09349881, 09350565, 10351851, 10353004, 11353005, 11355255, 12356822, 12356821, 02458856, 03460702, 04461615, 04461616, 06482947, 06485577, 07487906, 09496819, 09496826, 104109634 REF 38021156 Serial Numbers: 01210434, 01210187, 03210186, 05216627, 06215011, 07221035, 07219757, 11230053, 01335137, 01334292, 03336234, 03337223, 03338617, 03338467, 05341917, 05341626, 05341627, 05343892, 07345060, 07346548, 07347125, 08348592, 08348650, 08348651, 10349875, 10349876, 10351852, 11353006, 11353007, 12356823, 12356824, 03460703, 03460704, 03461618, 04478089, 04478090, 06482948, 07481393, 08487907, 09496820, 09496821, 09496827, 104109635, 035140879, 085227410, 105263402 REF 38021158 Serial Numbers: 01210090, 01210188, 01210178, 01210179, 01211740, 04214482, 05214483, 05216628, 09219758, 11231915, 12232598, 12233008, 01335132, 01335649, 02338979, 03338468, 04340568, 05343888, 06340567, 06344294, 07345059, 07347122, 07347669, 08348599, 08348656, 08348088, 08348655, 09349878, 10351853, 11353008, 11353009, 12355256, 12356825, 12356826, 02461607, 03461608, 03470677, 06485578, 06482949, 07487908, 07487909, 09496828, 10496822, 10496823 REF 38021160 Serial Numbers: 01210181, 02210613, 04215010, 04216152, 04220493, 05216630, 05216629, 07217493, 09222454, 09221582, 10229557, 11233006, 01334290, 01335133, 02335650, 02336236, 02335958, 03338469, 05340575, 05340917, 05343889, 06345058, 07347121, 08348597, 08348648, 08348649, 09349873, 10349874, 12353010, 12355257, 03461612, 04458858, 04461611, 07482946, 09485579, 094111524, 104109637, 104115132 REF 38021162 Serial Numbers: 01211738, 05216153, 06216039, 09221670, 11232597, 12233009, 02334559, 02336325, 03338470, 04338167, 05340918, 06340579, 06343891, 06345788, 08348658, 08351644, 08348657, 10351855, 11353011, 11349880, 02458859, 03470676, 04478092, 04461609, 04461610, 07485580, 09496824, 09496829 REF 38021164 Serial Numbers: 05221838, 07221839, 11228748, 03336238, 03338164, 04338471, 07340919, 08348660, 11351856, 02460705, 03461617, 03469914, 04478093, 04478094, 104109639, 104131404, 114115134 REF 38023642 Serial Numbers: 09350324, 11353708, 11355440, 12356827, 12358305, 12355961, 02461619, 03467498, 03467499, 04474158, 04474923, 06486901, 07489519, 07490801, 08493387, 015106754, 065238405, 065239235, 065238404, 065239234, 075239233, 075249939, 085243708, 095243272, 117488344, 028503774, 028534955, 078536231, 108660996, 108660998 REF 38023646 Serial Numbers: 085241470, 085243719, 095227398, 095248929, 016213548, 077447430, 1201215000 REF 38023844 Serial Numbers: 10351026, 11353709, 11355441, 12355962, 01456828, 02461620, 02467500, 03458306, 03467501, 06477921, 06486902, 07489602, 07490802, 08493388, 084108457, 094103606, 104106755, 065194653, 065209872, 065233350, 065209871, 075238406, 095263440, 096367013, 106370912, 126389852, 126389853, 027404927, 037410684, 057423324, 067432051, 067433168, 107471766, 107478040, 018488302, 028503775, 028535532, 038536232, 078591130, 078591129, 098632850, 098632851, 029751145, 049822074, 049822073, 089891762, 089891760, 0401092471, 1001214140 REF 38023848 Serial Numbers: 085227933, 095245939, 095243720, 095229803, 126391512, 037399260, 077447435, 068512955, 108690164 REF 38024046 Serial Numbers: 10351392, 11353712, 11355442, 12355963, 12356829, 02461621, 02468463, 03470699, 06477922, 06486903, 06483927, 07489603, 07490840, 08492533, 08493389, 104106756, 124125086, 055217545, 055235277, 055194655, 055194643, 055237142, 055237088, 065242425, 065214425, 065224742, 065238407, 065238408, 115280079, 016296716, 016299497, 066319600, 086365167, 086365302, 086368991, 096371767, 096369979, 096370913, 116382345, 116382801, 017391802, 017394120, 027402727, 027403683, 027404625, 027404972, 047408517, 047408534, 047408620, 067432524, 067434566, 077461151, 077452606, 087458203, 097464201, 107472436, 107466370, 107477129, 107477130, 127488334, 127495169, 127495171, 127485882, 038514074, 048536234, 048552438, 058573307, 068591131, 078591132, 078599923, 078599924, 078599925, 088669012, 108669011, 108706244, 108698530, 108698529, 019745467, 019745508, 019745509, 029789149, 039797034, 049830307, 059839748, 059848937, 059848938, 079876840, 089876839, 089886775, 089872994, 109927673, 109931107, 109938839, 109934908, 119922650, 010997992, 010976438, 0201014735, 0201016289, 0401068682, 0401074291, 0401074292, 0401105656, 0501116955, 0501116959, 0501117144, 0801170053, 0801170193, 0801170471, 0801170776, 0901170799, 0901170308 REF 38024050 Serial Numbers: 085247562, 085245192, 095239229, 095223311, 106369761, 126390839, 017396226, 097453678, 108674536, 029742801, 089912893, 119950530, 119960624, 1201215001, 0111276682 REF 38024248 Serial Numbers: 10351391, 11355443, 11353713, 12355964, 01456830, 02458308, 02461628, 02467503, 02468464, 02467502, 03474929, 06487066, 06477923, 06481754, 06486904, 07489604, 08490841, 09493390, 094106640, 104106641, 104106757, 104112181, 124125087, 045194639, 055194649, 055194644, 055194650, 055216559, 055194651, 055216560, 065218371, 065238410, 065238411, 065238412, 065218370, 095263441, 105275587, 105275586, 115286921, 125290208, 125290209, 125296715, 016299493, 026310216, 036308026, 036310214, 056331764, 056340024, 066340966, 066345839, 076351418, 076354546, 076355236, 086358753, 086362224, 086363652, 086364973, 086365305, 096369763, 096372048, 096371768, 106373446, 106374625, 116375748, 116379224, 116379861, 116382346, 116385705, 126382800, 126385704, 017392748, 017393061, 017393064, 027402728, 027404711, 027404889, 027404957, 027404822, 027404908, 037409911, 037413453, 037409910, 047415034, 047415537, 047418332, 057422837, 057422974, 057421989, 057422241, 057422973, 067434316, 067436159, 077439825, 077448326, 087448327, 087458829, 087460602, 097460603, 097465289, 107472437, 107475406, 107475407, 117480486, 117480487, 117482504, 117482503, 018489021, 018492018, 018492019, 018507054, 018505665, 018505666, 038510327, 038521161, 038521162, 048542052, 048542053, 058559024, 058559022, 068595144, 068595143, 068595145, 068595146, 068595147, 078599926, 078599928, 078599927, 078632854, 088632852, 088632853, 088632855, 098669014, 098669013, 098669015, 108706245, 108698532, 118698531, 019745512, 019745510, 019751974, 019745511, 019746513, 019755713, 029784162, 029784161, 039789315, 039805753, 039805752, 049797035, 059835269, 059835267, 059835268, 059848939, 059835270, 069849865, 069859717, 079859142, 079881858, 079881568, 079876947, 079859143, 079881859, 089894763, 109934909, 109938840, 109934278, 129976440, 129982434, 010988035, 010976439, 010988032, 010974120, 0101000339, 0201016290, 0401081727, 0401081728, 0401081729, 0401081730, 0401109397, 0501109172, 0601131438, 0601131569, 0601131795, 0601139882, 0601139890, 0701140035, 0701160492, 0701152897, 0701159670, 0701160631, 0701161355, 0701162969, 0701160802, 0701162473, 0901200096, 0901200601, 0901201664, 0901200095, 0901200882, 0901200720, 1001197624, 1001200695, 1001200881, 1001201559, 0611360333, 0711372578, 1372577 REF 38024252 Serial Numbers: 085255780, 085239230, 085243721, 085247551, 095246754, 126390846, 017394340, 017394545, 077447437, 097455544, 048542054, 108690173, 109934275, 119960626, 0901188067, 1001215002, 0111251442 REF 38024450 Serial Numbers: 09350262, 09349142, 09350115, 11353719, 11354702, 12357147, 12356831, 12355965, 12358309, 01461703, 02461623, 03468465, 0547638301, 06477927, 06476159, 06486905, 07490842, 094103586, 08492535, 08493391, 094104974, 104106759, 104112182, 114121286, 114132499, 124125088, 124137037, 035174263, 035194638, 045194606, 045194136, 045194605, 045194608, 055194613, 055194607, 055194610, 055194645, 065223933, 055216992, 065217570, 075238413, 075238415, 085245388, 085257643, 085257642, 095263442, 095263443, 095274090, 105271963, 105271964, 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079869502, 079876944, 079864574, 079869500, 079886776, 079876943, 079881569, 079881861, 079888795, 089891750, 089891751, 089894764, 089918974, 109929573, 109931108, 109929570, 109934279, 109934280, 109937607, 109937608, 109931109, 109934910, 010993337, 010997993, 0101007905, 0201018650, 0401064284, 0401064285, 0401064287, 0401064286, 0401082847, 0401082848, 0401082849, 0401087822, 0401087821, 0401107486, 0401107495, 0401107779, 0501119676, 0501119807, 0501119001, 0501120035, 0501121016, 0601143233, 0601142473, 0601143603, 0601149887, 0701143642, 0701148779, 0701150010, 0701150371, 0701148938, 0701151568, 0701148839, 0701149974, 0701151024, 0701150479, 0901189894, 0901189693, 0901190669, 0901189483, 1001190507, 1001189096, 1001189895, 1001190396, 1001188996, 1001188997, 1001215443, 1001215446, 1001215445, 1001219490, 1001220129, 1101220735, 1201220736, 1390053, 1390581, 1390582, 1390054 REF 38024454 Serial Numbers: 085241471, 085232810, 095248927, 095224679, 106369765, 126391998, 017396071, 017395941, 107474922, 078626663, 108690167, 109934276, 0901161798, 0211276683 REF 38024652 Serial Numbers: 10352354, 11353720, 11354704, 11355444, 12356832, 12355966, 01461308, 02461629, 02458310, 02461632, 03470703, 04474928, 04476381, 04481752, 04476160, 06477924, 06486906, 07491124, 07489605, 08490843, 08497446, 09499516, 094104972, 094106639, 104106760, 08493392, 104112183, 104115094, 114121287, 114132500, 124140492, 124137034, 124125089, 015145845, 015154241, 025170054, 025179499, 035179500, 035179930, 045194135, 045191754, 045191755, 045194646, 055208754, 055218368, 055216996, 065218369, 065242426, 065238416, 065226063, 065226062, 065229817, 075236077, 075236080, 085247565, 085210118, 085243280, 085245196, 095257644, 095257645, 095263444, 095263445, 105275588, 105275589, 115285362, 115283561, 115285361, 125291384, 125292871, 125292872, 125297568, 125298246, 016302639, 016300606, 016304478, 016306333, 026306192, 026308036, 026301494, 036307857, 036319616, 036306332, 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0801177946, 0801178424, 0901201671, 0901202141, 0901208952, 0901206427, 0901206827, 0901206828, 1001208902, 1001207003, 1101224431, 1101226278, 1101224786, 1101226279, 1101223411, 1201223412, 1201225276, 0111271043, 0111271044, 021109196901, 0311298956, 0311298729, 0311297746, 0311301303, 0311300499, 0311302171, 0711367090, 1367091, 1389339, 1388484, 1389318 REF 38025060 Serial Numbers: 085239232, 085233857, 095248925, 095245194, 126379851, 017394685, 047417326, 067424424, 028489093, 128690172, 1201215005 REF 38025258 Serial Numbers: 10352357, 1135371, 11354708, 12355970, 12355447, 12356507, 0145831, 02461625, 02461633, 03474933, 04470705, 04476161, 04477925, 06476847, 06483932, 06486909, 07489608, 08492537, 08493395, 094106638, 104106763, 114115096, 114132513, 124140885, 124140884, 015145848, 025158582, 025158583, 02517005, 025179495, 035174265, 035179935, 035179934, 035191026, 035191027, 035196042, 045191025, 055201255, 055203650, 055203648, 055203651, 055203649, 065238422, 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0601128424, 0601128516, 0601128929, 0701159632, 0701159633, 0701159634, 0701166275, 0701168075, 0801180197, 0801179738, 0801180406, 0801180941, 0901192056, 0901192047, 0901180922, 0901181122, 1001210463, 1001211474, 1001210498, 1001210582, 1001210499, 1001210581, 1201226441, 1201226442, 1201227207, 0311302200, 0311301304, 1388485 REF 38025262 Serial Numbers: 075233858, 075241469, 095245938, 095248930, 095246449, 106378064, 057422440, 077444057, 107455547, 1101215006 REF 38025460 Serial Numbers: 10352358, 11353716, 11354709, 12356508, 01460246, 02461622, 03468467, 03476157, 04476844, 06480457, 06477926, 06481572, 07486910, 07489609, 08491639, 09493396, 094104310, 094104973, 094106637, 104106764, 114115097, 124132514, 124140888, 015145849, 025158585, 025158584, 025168554, 025174264, 045202460, 045191029, 045195905, 055191030, 055194657, 055203655, 055203656, 055203654, 065224678, 075203653, 095243710, 105249032, 095249031, 125287552, 125289070, 026308169, 026300066, 026302359, 026303106, 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0501115946, 0501115989, 0501116685, 0801170012, 0901195837, 0901194928, 0901195836, 0901195911, 0901196549, 0901196550, 0901196447, 0901194929, 1001196448 REF 38025464 Serial Numbers: 085243723, 085246755, 095233859, 095241467, 105247552, 077439832, 077445974, 107455549 REF 38025662 Serial Numbers: 10352359, 11353717, 12356509, 01457265, 01460791, 02469036, 02461630, 05476158, 0547684501, 06486911, 07489520, 08491640, 09493397, 104106765, 104115098, 015132515, 065220935, 075236068, 075226065, 095245392, 105249030, 105249029, 105276757, 036308171, 056337107, 056340967, 066347287, 086354548, 096368993, 106366892, 106379852, 116384886, 116385706, 126391089, 126391530, 126392675, 017395055, 017397400, 027402152, 027402619, 027402665, 027403039, 027404975, 027405221, 057408595, 067432539, 067433167, 087457365, 107472441, 117480802, 018489023, 018496156, 058525932, 068542059, 078605248, 088632934, 098632935, 098689070, 118690174, 019743159, 019743160, 089891755, 089891754, 0201010925, 0401044694, 0501092472, 0111251444 REF 38025664 Serial Numbers: 09350844, 09351027, 11353718, 11354712, 01456510, 02461626, 04476846, 04476162, 06486912, 07489521, 08491641, 09493398, 104106766, 015132516, 075194654, 095245390, 105249028, 105226068, 105249026, 115276758, 086352237, 047409712, 057431542, 107468825, 107472442, 018512937, 028533629, 058564159, 8886049, 118690171, 049793763, 0401092473 REF 38025666 Serial Numbers: 065126156, 065126160, 065126158, 095233864, 105246733, 056329101, 066345261, 076356213, 106378066, 126386077, 126391618, 077447442, 107468826, 107472443, 117486700, 078597082, 049813586, 089871780, 129966585 REF 38025668 Serial Numbers: 095236076, 095236079, 105248926, 066345262, 106372046, 126391644, 077439829, 097455551, 127472468, 019742002, 089869226 REF 38123844 Serial Number 116385405 REF 38124046 Serial Numbers: 017385408, 018487311 REF 38124248 Serial number 126385409 REF 38124450 Serial Numbers: 116385597, 38124450 REF 38125056 Serial Number 126385598 REF 38125662 Serial Number 126385601 REF 38HA3642 Serial Numbers: 10350323, 01457571, 03458815, 03470678, 04476203, 07480515, 08484521, 096367015, 126381292, 027389855, 027389854, 077440594, 087454147, 107460690, 107461471, 018485759, 0601122157, 0601125125, 0601126032, 0601126242, 0601126459, 0601126069 REF 38HA3844 Serial Numbers: 10351025, 03458816, 03468462, 04470679, 05476204, 05480386, 06480516, 06484522, 08491108, 096365741, 096365931, 116377348, 027390207, 067422787, 077437510, 077442057, 097450998, 097460691, 088591133, 1101215442 REF 38HA4046 Serial Numbers: 10351390, 03458817, 03461670, 03469317, 04470681, 05476205, 06480517, 07484523, 036303472, 066334882, 066337110, 096365932, 096368056, 106370677, 027382202, 027382203, 057420785, 067425755, 067426458, 067426766, 087444754, 107460692, 018485760, 078532247, 098632957, 118690190, 118706238, 059833593 REF 38HA4248 Serial Numbers: 09351389, 10355712, 03458818, 03469318, 04470682, 06476206, 06480518, 06487070, 07491125, 07484524, 114115100, 105262959, 125281585, 016297587, 066332639, 076337112, 086358034, 096362315, 106372709, 106373443, 106376540, 116380023, 126385209, 027392300, 027388274, 027388275, 047407493, 047416541, 057417312, 057418553, 067426459, 067426460, 067430920, 067430921, 077437753, 077444755, 087442058, 087456537, 097460693, 107463825, 058525925, 068573302, 078573303, 078605231, 088591134, 088632958, 108668995, 118706239, 118690191, 049819957, 059834726, 069847482, 069847484, 089886766, 099888799, 0501062358, 0501062359, 0601139753, 0601139754, 0801164227, 0801163078, 0801163564, 0801163087, 0111231469, 0111231470 REF 38HA4450 Serial Numbers: 09350261, 01457572, 02458819, 03469038, 03461888, 03469319, 04461671, 04470684, 04474922, 06481750, 06480519, 104115163, 114115101, 065208753, 095249049, 105262958, 105268088, 115281169, 125283320, 026301523, 036301385, 076333743, 076349355, 076349880, 096362316, 096366899, 096370242, 106370241, 106372710, 106376226, 106378168, 116380025, 116381300, 116381299, 126385208, 126385920, 017388276, 027392677, 027388277, 027392676, 027395039, 027395040, 057419214, 057419215, 057421518, 057421519, 067426462, 067426461, 077435309, 077437754, 077444756, 097455274, 097455273, 107460694, 107463826, 107464073, 018499154, 018483303, 018489027, 018483304, 028498236, 058552439, 058530726, 068552440, 068580396, 068580397, 078587972, 078580398, 078587973, 088610360, 098632960, 098632961, 098632959, 108690188, 108690189, 118690187, 118706240, 049789147, 049819955, 049819956, 059834728, 059834729, 069852485, 069852484, 079861034, 079861033, 089886771, 089872401, 099894761, 109933794, 119937611, 119932182, 010964134, 020989173, 020993334, 0301036769, 0301036770, 0301036771, 0401062360, 0501062361, 0501062362, 0701146209, 0701148132, 0701146416, 0701147759, 0701148209, 0701147183, 0701151659, 0701147141, 0801152798, 0901165715, 0901188153, 1001188447,100118815, 1001188446, 1101219268, 1101219489, 1101220029, 1101218551, 1101219307, 1101218550, 1101218647, 1201217382, 1201220127, 0111218648, 1388731, 1388683 REF 38HA4652 Serial Numbers: 10351677, 01457573, 02461300, 02469037, 03461672, 03461887, 03469320, 03470685, 06480520, 07476420, 07491126, 07484526, 055199122, 065208751, 075246934, 085239332, 085239328, 105257908, 105258454, 105263397, 125284389, 125284392, 046305910, 046318362, 046320015, 056328083, 066331047, 066333744, 076349349, 076349877, 076349878, 086358750, 096369827, 096369826, 096370922, 106372711, 106373197, 106373236, 106376225, 106376541, 116380026, 116380027, 116381301, 116381303, 116382198, 126381302, 126382199, 126385207, 126385921, 017387713, 017387715, 017387714, 017387716, 027399382, 027399487, 027399288, 027399028, 047416892, 057421381, 057420301, 057422432, 057422656, 057422655, 067426463, 067426464, 067434205, 067435310, 077451737, 087438256, 087444757, 087453680, 087454746, 097458777, 097458778, 107464079, 097460695, 107464080, 117464871, 018480873, 028480872, 028480871, 028510035, 028489931, 048525926, 048542034, 048525927, 048542035, 058564156, 068564155, 078580399, 078580400, 078610362, 088610361, 088580401, 098610363, 098610364, 098610365, 098632966, 098675494, 098675492, 108632962,108675493,029779623, 029770575, 039770576, 039779618, 039780065, 049824243, 049824241, 049824244, 049824245, 059832449, 059832447, 059836822, 069852486, 079864670, 089864669, 089872402, 089886772, 089861036, 099861035, 099888800, 109920497, 109929515, 119929518, 119933796, 119937612, 119934905, 129964136, 0201000336, 020989175, 020997990, 0301018649, 0401058386, 0401058385, 0501106403, 0501106435, 0501058387, 0601126907, 0601127072, 0601127372, 0601127374, 0601128456, 0601128926, 0601129587, 0601126743, 0601127373, 0601129967, 0601146205, 0701146193, 0801164901, 0801164903, 0801165793, 0801164902, 0901165757, 0901169306, 0901181697, 1001169432, 1001181766, 1001199582, 1001199581, 1001199812, 1001199811, 1201222242, 1201224787, 1201220901, 0111224788, 0111240527, 1390645, 1391137, 1389787, 1389786 REF 38HA4854 Serial Numbers: 09351679, 01457574, 02458820, 02461295, 03469838, 03461673, 03461889, 04470686, 06480521, 07492649, 08484527, 104115235, 114109645, 114109644, 065208750, 075225816, 075238425, 075213417, 085249130, 095247553, 283540, 095249131, 105268091, 105263393, 125281235, 016289071, 016290342, 026300071, 046308473, 046308472, 056328085, 056331050, 066331049, 066331765, 086349356, 096366368, 096368480, 096368481, 096369828, 096369830, 106372712, 106373199, 106373234, 106376227, 116380029, 116381025, 116381026, 116381567, 116381568, 126384887, 126384888, 126385206, 126386057, 017392400, 027392398, 027395041, 027395042, 027392301, 027389026, 037407056, 047406584, 047407055, 047407314, 047416769, 057419738, 057421380, 057421520, 057421521, 067429969, 067429971, 067430369, 067430370, 067429970, 067436643, 067435215, 087436062, 087439822, 097444758, 097454156, 097454750, 097459523, 097459522, 097459526, 107464081, 107464082, 018476160, 018484874, 018489028, 018476159, 028489029, 038500375, 048500373, 048530652, 048530653, 058542036, 058597763, 068570143, 068570166, 068542037, 078580403, 078605232, 088580402, 088610366, 088610367, 088610369, 09861068, 098580404, 108675511, 108632967, 108675510, 118675509, 029774821, 029767188, 029767189, 039781884, 039781879, 049799040, 049824250, 049819958, 049824251, 059831041, 059831042, 059833594, 059834727, 059836823, 059836824, 079861041, 079861042, 079876838, 089876837, 089864668, 089864667, 089913068, 099886774, 099888801, 099886773, 099891756, 109933196, 109922085, 109924909, 109933797, 119934277, 119934906, 119929560,119929563, 119938842, 119941246, 010964140, 010989176, 010989179, 020992249, 020989178, 020998810, 0301016208, 0401048255, 0401048260, 0401059409, 0401048261, 0401059410, 0401059411, 0401059412, 0501110409, 0501109575, 0501110700, 0501111076, 0501109546, 0601130018, 0601130019, 0601131091, 0601131094, 0601129588, 0701131146, 0701131796, 0701146208, 0701146414, 0701147123, 0701147038, 0801148207, 0801167201, 0801167683, 0801167878, 0801168073, 0801178784, 0901168109, 0901179431, 0901178475, 0901179479, 0901187952, 0901179737, 1001211475, 1001211644, 1001211645, 1001212245, 1001212246, 1101212320, 1201234144, 1201237625, 0111236530, 0611332567, 0611336869, 0611337688, 0611338278, 0611333205, 0711338331, 1372619 REF 38HA5056 Serial Numbers: 10351680, 10355708, 01457576, 01458821, 02459807, 03461674, 03461886, 04470688, 04474932, 06477917, 07480522, 07484528, 114115102, 035140900, 045204369, 045197064, 055199124, 055201257, 085239333, 085255780, 085239230, 085243721, 085247551, 095249048, 095246754, 095257909, 105263395, 115268092, 115281236, 125283562, 016293918, 026300601, 036305909, 046318112, 046319438, 056328084, 066331048, 066340885, 066332638, 086329114, 086361624, 096362317, 096368505, 096366127, 096366776, 096370244, 106370243, 106373235, 106376228, 116380030, 126381027, 126381028, 126381565, 126381566, 126381029, 126384889, 126384890, 126390846, 126385205, 126386058, 017394340, 017394545, 017389027, 027388279, 027393902, 027398139, 027397687, 027398140, 027397688, 027397689, 047407490, 047407491, 047408536, 057419746, 057422788, 057425756, 057420894, 057420893, 067426465, 067426466, 077434229, 077434230, 077447437, 087436466, 087440352, 087450443, 087450444, 097454148, 097456830, 097456831, 097455544, 097460696, 117467596, 117474150, 117465284, 117474149, 127478248, 127478249, 028499155, 028489031, 028489030, 048542054, 058525928, 058510320, 068542038, 068564158, 068542039, 068580405, 068564157, 068580406, 078525929, 088610373, 098610372, 098610370, 098610374, 098610371, 108675506, 108675508, 108690173, 108675507, 108632968, 108690192, 029780126, 039777520, 039781885, 039780127, 039802338, 039802339, 049580407, 049832441, 059832442, 059828316, 059836825, 059836827, 059836826, 079852488, 079864592, 079869493, 079864593, 099881566, 099881855, 099852489, 099881565, 099881854, 099891759, 099894762, 109915888, 109934275, 109918959, 109924910, 109929568, 109929565, 119927672, 119933798, 119934907, 119937613, 119939757, 119960626, 129955349, 129964142, 129953506, 020993335, 0201000337, 0301016266, 0301022075, 0401057257, 0401057256, 0401057255, 0401066510, 0401066511, 0501108635, 0501108734, 0501111548, 0501112333, 0501111879, 0501112415, 0601132633, 0601134956, 0601136357, 0601137370, 0601137650, 0601136263, 0601136356, 0701146048, 0701146096, 0801151514, 0801164912, 0801164304, 0801165752, 0801169435, 0801146095, 0801164910, 0801168110, 0801168336, 0801169305, 0801171295, 0801171320, 0901188067, 1001192134, 1001207893, 1001207779, 1001207780, 1001207894, 1001208848, 1001207778, 1001215002, 1001208341, 1101208342, 1201222243, 1201223349, 0111234049, 0111234050, 0111251442, 0111272298, 0111272299, 0111271874, 0111271875, 0511308186, 0511308414, 0611324905, 061906113279, 0611331606, 0711326406, 1366167, 1367054, 1364791, 1366503, 1364792, 1365358, 1366202, 1366502, 1365976, 1366691 REF 38HA5258 Serial Numbers: 10351683, 01457577, 01458822, 03461675, 03461885, 04470693, 06477918, 07480523, 07484529, 055199123, 055200362, 065208752, 075238426, 085244939, 095247554, 105257910, 115268090, 105262960, 125283564, 046318360, 056328086, 066331051, 076333745, 076349357, 096358751, 096362318, 096368055, 096368463, 096368465, 096370680, 096370681, 116376543, 116376224, 116380031, 116381760, 116382196, 126381761, 126387391, 126382197, 126384891, 126386055,126384892, 017388281, 017392324, 027394452, 027396127, 027396128, 047406500, 047406501, 047406502, 057416924, 057418972, 057420891, 057419945, 057420892, 057422658, 067422657, 067426468, 067426467, 077436063, 077436064, 087438258, 087445967, 097455539, 097455540, 107460697, 107464139, 117464140, 018489032, 028478246, 028466273, 028497145, 028478247, 028510321, 078542048, 078570086, 078570085, 078542049, 078587975, 078587974, 088605233, 098632969, 098610375, 098610377, 108675495, 108675496, 108675497, 128610376, 049789148, 049809748, 049809749, 059832445, 059832443, 059832444, 069848936, 079861037, 089852491, 089861039, 089869497, 099886767, 099869495, 099888802, 119933799, 119938843, 010964145, 020985908, 020989180, 020992250, 020998811, 0201007904, 0201014727, 0301019956, 0401052977, 0401052978, 0401064255, 0401064256, 0401064258, 0401064257, 0601132449, 0601132598, 0601137869, 0601138316, 0601138559, 0601138640, 0601138737, 0801158631, 0801158963, 0801159459, 0801157870, 0801159617, 0801165859, 0801166510, 0801167388, 0901181129, 1001191345, 1001191509, 1001191510, 1001190670, 1001209961, 1001209071, 1001209884, 1001210462, 1101209885, 1101209978, 0111232452, 0111232453, 0111232451, 0111232815, 0411295492, 0411295493, 0411295978, 0411296908, 0411297627, 0511316422, 0511324007, 0511315048, 0511315483, 0611323583, 1389117, 1392011, 1389116 REF 38HA5460 Serial Numbers: 10351684, 01459808, 03461676, 03461883, 04470695, 06477919, 06480524, 104115083, 104115104, 104109646, 075243709, 085246852, 095247563, 125281584, 046308471, 046308470, 066333746, 076339868, 086356209, 096362323, 096366900, 096370683, 106376542, 106373877, 106378166, 116380032, 126382200, 126382201, 126386056, 017388287, 017393903, 017394313, 027395036, 037406211, 047406212, 047406213, 057419199, 057417069, 057423455, 067426469, 067431585, 067431755, 087436644, 087435312, 097442059, 097445968, 107460698, 028497148, 028464141, 028482232, 028482233, 068510322, 068542050, 078542051, 078587976, 098587977, 098610378, 098605234, 098632970, 118690193, 099881567, 099864591, 119937614, 010989182, 0201014728, 0301022076, 0301036772, 0301036773, 0401074289, 0401074290, 0501095299, 0501095300, 0501112416, 0501112417, 0501112418, 0701149973, 0701148933, 0701149886, 0901169801, 1101214187, 1101214886, 1101214832, 1101214884, 1101214885, 0111231473, 0111239139, 0111231876, 0511310150, 0511310909, 0511311537, 0511311744, 0511311814 REF 38HA5662 Serial Numbers: 10351676, 10355131, 01459809, 03461884, 03469321, 04470697, 04474920, 06480525, 06477920, 104115214, 125281170, 026303120, 066337111, 096361493, 096367016, 106376223, 116380033, 017392646, 017396851, 027396943, 027397399, 027396941, 057416992, 067423456, 067426470, 077436065, 087445969, 097460002, 107464142, 127483305, 068498238, 088605235, 088591135, 098530727, 0301044686, 0401059751, 0401078361, 0501115065, 0801161846, 0111235747, 0211272958, 0511313423, 0511313435, 0511314290 REF 38HA5664 Serial Numbers: 09350843, 10354989, 02461677, 03461882, 03469322, 03476412, 04470698, 05476416, 06480526, 07481753, 07487069, 104115234, 096365742, 106377968, 116380035, 126387528, 057417311, 087438016, 097455541, 097460722, 097471730, 097460898, 117474920, 068512936 REF 38HA5864 Serial Numbers: 058552898, 039625643 REF 38HA6066 Serial Numbers: 058552899, 029625644 REF 38SP3642 Serial Numbers: 01460611, 01458691, 04476380, 06482400, 07487296, 094101412, 085249035, 105268094, 016293914, 016297806, 016307972, 026303425, 048555412, 058585777, 108591463, 019729900, 089891764, 0701146210 REF 38SP3844 Serial Numbers: 01460490, 01458018, 01458700, 02464738, 06482401, 07487297, 104101413, 105268095, 115277303, 125291159, 016297807, 016303426, 016305136, 016306338, 026306569, 026307973, 026307974, 028521165, 048555413, 088605718, 108703701, 128729892, 049831539, 128745506, 089901155, 0201034749, 0701152845, 0511338273 REF 38SP4046 Serial Numbers: 01458699, 02461704, 03464739, 0548239801, 07487298, 094101439, 045202455, 045203184, 085243711, 085249036, 095249132, 105269111, 125297713, 125293913, 016301752, 016304476, 016304872, 076352016, 086352019, 096370923, 047422277, 057428266, 067431993, 107468479, 117478142, 117481326, 127494344, 127494345, 038518016, 038518044, 058547851, 088595162, 088571499, 088605239, 108694944, 128717764, 128739658, 049828314, 059840554, 059850352, 039816364, 059850487, 089894841, 099911142, 099919584, 129933777, 129976435, 0301029703, 0401081722, 0401081724, 0401081723, 0801165753, 0801165581, 0311282910, 0511333356, 0611364796, 0711364797, 1397043 REF 38SP4248 Serial Numbers: 01458698, 02458020, 02461245, 02469039, 06481751, 06482402, 07487299, 094101415, 104115085, 015132517, 025170196, 035184142, 045194642, 055185236, 065223814, 085249133, 095260570, 105268096, 105276178, 115281568, 115284378, 115285441, 125304796, 016308622, 026313449, 036317581, 036318403, 066347936, 066350147, 066348426, 076351538, 076352021, 086366377, 096370924, 126385915, 126381295, 047416045, 057417818, 067431545, 087437826, 087451777, 097463811, 097464161, 107469155, 117480304, 117479563, 117479938, 127495717, 018506081, 028506082, 028507047, 028518270, 028518272, 048547853, 058547854, 058570068, 088610393, 088610394, 098668999, 108669000, 118694943, 118706247, 128740265, 128728420, 128728421, 019742800, 029780064, 039816365, 039820459, 049823317, 059841527, 059836598, 059846057, 069863140, 079875068, 079879069, 099914630, 099919585, 099924911, 109934911, 109933778, 129976436, 010983795, 0201014729, 0201027429, 0301044383, 0401069677, 0501114365, 0501117145, 0501118630, 0801169936, 0801170136, 1101226387, 1101226388, 1101228040, 1101228976, 1101229754, 1101229790, 0511349862, 0611348361, 1384742, 1397044 REF 38SP4450 Serial Numbers: 01458021, 01458693, 02461244, 0548240301, 07487300, 09497831, 094101416, 08492531, 114118373, 015132521, 035184141, 055208749, 065223815, 085246254, 085246819, 095260571, 105268097, 105276179, 115282069, 115283804, 115285442, 125291157, 016300053, 125304798, 026308623, 026313454, 036319130, 046322461, 056333076, 066343521, 066347831, 066347893, 066343520, 076350148, 076351537, 076351292, 096366646, 096366904, 096370925, 096369276, 106373970, 106375112, 106377462, 116379847, 126380542, 126382205, 126382793, 126385916, 057416697, 057416893, 057424666, 057422972, 077431804, 077437825, 077438093, 077438942, 087451778, 077449073, 087459166, 107461968, 107461969, 117475404, 117479939, 127475405, 127490506, 127505664, 127505663, 127480804, 127484397, 038507073, 038514071, 048529203, 048540093, 058529178, 058555414, 058555415, 058570167, 058540092, 078595163, 088552307, 088610403, 088610401, 088610402, 088585977, 088585978, 088673578, 088610404, 088669005, 088669001, 098669004, 098673577, 098673579, 098673580, 108687210, 108687211, 128728419, 128734875, 128728418, 128734973, 128742799, 128741079, 039802342, 039806006, 039819341, 049821646, 049825294, 059841528, 059846058, 059847478, 079876939, 079872397, 079875070, 079881856, 089894766, 089911143, 099914631, 099922651, 099919586, 109927674, 109933779, 109931110, 109934912, 109937617, 010985814, 010997991, 0101000338, 0201014730, 0301027430, 0301027431, 0301043280, 0301043279, 0401082845, 0401082846, 0401097010, 0501097011, 0501119808, 0501121084, 0501122161, 0601123381, 0701159671, 0801159372, 0901195814, 0901196552, 0901195265, 1001196408, 1001196507, 1001197583, 1201235134, 1201236259, 1201236531, 0211288442, 0211289480, 0211287876, 0311287774, 0511333209, 0711365967, 0711371896, 1375060, 1378947, 1397268, 1397266, 1397267 REF 38SP4652 Serial Numbers: 01458690, 01460444, 02461243, 03469847, 06482404, 07487301, 09497832, 094101417, 124115087, 015140902, 035184136, 035184137, 065226055, 075246259, 085243712, 085255289, 095260572, 095268098, 105276180, 115277306, 115283805, 115291156, 125304522, 125304818, 125297808, 026311875, 026314526, 036317580, 036318402, 036322462, 046332240, 056332187, 056333075, 066343519, 066345604, 066347686, 066344949, 076355231, 076357095, 076355232, 086358848, 086358849, 086366156, 096366647, 096368054, 096369277, 096370926, 096372043, 106374633, 106377463, 106376230, 126379848, 126382204, 126385917, 126380541, 037395738, 037405944, 037405346, 047412008, 047418561, 057424030, 067430373, 067430374, 067433688, 087438337, 087437434, 097459246, 107462476, 107462475, 107464144, 107470860, 107464469, 107466321, 107466320, 018485763, 018480488, 018480489, 018491998, 018490508, 038493740, 038503870, 038507074, 038536236, 048515238, 058520160, 058536235, 058520161, 058547855, 058512206, 058547858, 058559020, 058570168, 088585980, 088610405, 088585979, 088610407, 088610408, 088610409, 088610406, 098669008, 098673587, 098687208, 098673591, 098687209, 108673588, 108673590, 108669007, 108669006, 108673589, 128733508, 128733510, 128733509, 128743359, 128739166, 128739165, 039819340, 039820460, 049821647, 059836599, 059840553, 079875073, 079872399, 079876940, 079881857, 089891766, 089894842, 099915889, 099922652, 099919587, 109927675, 109931111, 109933780, 109924912, 109934286, 129969845, 010989100, 0201013707, 0201014731, 0201013706, 0201034750, 0301059417, 0301064276, 0301064277, 0401071246, 0401089745, 0401089746, 0401089747, 0601126460, 0601131830, 0601131440, 0701156631, 0701157618, 0801167389, 0801168337, 0901193745, 0901192625, 0901192473, 1001216163, 1101220082, 1101218826, 1101220083, 1101216897, 1201237629, 1201239312, 0211290884, 0211293924, 0411293923, 0411303407, 0411304964, 0511338274, 0511346104, 051133827410, 0711365965, 0711367621, 0711367622, 1374873, 1383902 REF 38SP4854 Serial Numbers: 01458692, 01460492, 06482405, 07491106, 08492532, 09497833, 104101418, 114115088, 124132518, 015135085, 035184138, 055185237, 065238427, 065245742, 065227408, 065226059, 085246818, 085253432, 085255290, 095260573, 105268099, 105276181, 115282071, 115285444, 125291155, 125293915, 125297809, 026308624, 026313053, 026316328, 036317025, 036319551, 056329823, 056330210, 056331488, 056330211, 066345602, 066345605, 086357097, 086358846, 086358847, 086362907, 086366128, 086366645, 096366775, 096368484, 096370927, 096369279, 106379221, 106374631, 106375747, 106376548, 106377465, 017381296, 017380259, 027385918, 037406825, 037402118, 047417012, 047417346, 047420834, 057423364, 057428676, 057424026, 067430763, 067433847, 087435343, 087436353, 087436354, 087442238, 087442516, 097461414, 097461411, 127484398, 127466322, 127469156, 127466323, 127485761, 127491897, 127491999, 127485762, 038525560, 048503772, 048515239, 048540095, 048500377, 048512207, 058506875, 058506876, 058540097, 058540094, 058540096, 058530728, 088610410, 088585982, 088591454, 088585981, 088610411, 088610412, 098673582, 108610413, 108610414, 108669009, 108673584, 108673585, 108673586, 108669010, 108673583, 108687206, 108687207, 128734974, 128737871, 019742679, 049820458, 049820461, 049830835, 049828315, 049823318, 049837284, 079875075, 079862975, 079876941, 079872400, 089883244, 089901156, 089909600, 099915890, 099919588, 099922086, 109931112, 109934287, 109927677, 010982436, 010982437, 0101011468, 0101011381, 0201011469, 0301043284, 0301043285, 0401085772, 0401085771, 0501085773, 0501098049, 0501098050, 0701147760, 0701148832, 0701149976, 0701151551, 0801186488, 0801186489, 0801186853, 0901188007, 1001201339, 1001204319, 1101220903, 1101225238, 1101224739, 1101225255, 0311291059, 0311292219, 0311295982, 0311296734, 0511352221, 0611352222, 0711373364, 0711373917 REF 38SP5056 Serial Numbers: 01458694, 01460491, 01458024, 03464741, 06482406, 08492530, 09497834, 104101419, 104115089, 015140901, 025145855, 035184139, 055194640, 085246817, 085253433, 085255291, 095264011, 105268100, 115276182, 115282073, 115283806, 115285445, 125291154, 016301751, 026308625, 026313443, 036314527, 036320563, 036321078, 066343522, 066343523, 066351923, 076358778, 076358838, 076354494, 076356436, 076357096, 086358850, 086366130, 086366780, 086366901, 096369281, 096370928, 106368485, 106373969, 106375110, 106376229, 106379849, 116378759, 017387710, 017381297, 017382792, 027402351, 037405309, 047415594, 047417530, 047420022, 047422278, 067428677, 077433689, 077435341, 077437211, 077435342, 077438920, 087442984, 097461359, 097461298, 107465346, 117465347, 117468480, 117479940, 018480813, 018492000, 018495718, 018500379, 018485440, 018485439, 018503773, 048507048, 058520163, 058520162, 078610417, 088547866, 088585983, 088610415, 088559021, 088585984, 088547864, 088547865, 088591455, 088610416, 108610418, 108694945, 108687205, 108687204, 108694946, 128738618, 128738620, 128739164, 128739163, 049821648, 059848064, 059852885, 069853360, 089883245, 089876942, 089885354, 089894843, 109931113, 109937619, 010998812, 0101011470, 0301034751, 0301027433, 0301048282, 0301048256, 0501098051, 0601137658, 0701141383, 0701144435, 0801188771, 0901191511, 1001198261, 1001199233, 1101235014, 1101234145, 0111246351, 0311287311, 0311287709, 0311297749, 0711358258, 0711361493, 0711363269 REF 38SP5258 Serial Numbers: 01458697, 01460612, 0548239901, 09497835, 08492051, 104101420, 114115090, 055213416, 065241610, 085243713, 095250532, 095260574, 105264012, 105276183, 105268101, 115285446, 125301454, 125297811, 016301750, 036316329, 036322103, 056332186, 066342429, 066343525, 076355229, 076356369, 076355230, 086358698, 086358699, 086362908, 086366129, 086366902, 086366903, 086368486, 106370929, 106376547, 106374632, 116378760, 116380257, 126382788, 126387711, 037409024, 057416264, 057419194, 057423765, 057424683, 087437210, 087439291, 107464145, 107464468, 107471696, 018490509, 018493739, 018501069, 048495672, 048514243, 048473532, 048514244, 088547870, 088566751, 088547868, 088591457, 088610422, 088610420, 088610421, 098547869, 108610423, 108706248, 128740266, 128729912, 128742680, 049832439, 049832440, 089909601, 109932183, 129984897, 0101001911, 0301044384, 0501095044, 0701154048, 0701155554, 0701154839, 1101231806, 1101231849, 1201231235, 0511332572, 0511331743 REF 38SP5460 Serial Numbers: 01458696, 01458026, 02460613, 02469848, 0548240701, 08492529, 104101421, 114115091, 124118375, 015132519, 075259697, 085250534, 095260575, 105268102, 105276184, 125285447, 125304535, 125297813, 036319133, 036314528, 056339870, 066343524, 066345263, 076354495, 086358852, 096366151, 096368487, 096370930, 116379220, 116381298, 027387712, 057419668, 067436599, 097438617, 097458646, 127479564, 127484399, 028502180, 028502181, 028520164, 058536238, 078547871, 078566752, 078591462, 098610425, 098610424, 118706249, 019740991, 128743357, 089891172, 109932184, 0201010914, 0301044687, 0401081069, 0701127364, 0111251441, 0211273041, 0711346217, 1397045 REF 38SP5662 Serial Numbers: 01458695, 01458027, 02460614, 05482408, 094101422, 015115105, 015132520, 105268103, 105275860, 016301452, 016301749, 036305130, 036306570, 116380258, 126385919, 057427752, 077439292, 087449459, 018478143, 028514246, 048547872, 058566753, 078605240, 098610426, 019729911, 099911491 REF 38SP5664 Serial Numbers: 01457885, 01458677, 03460615, 05482409, 094101425, 085249037, 276185, 105285402, 105269113, 125285448, 036307986, 066332044, 066332043, 087458645, 018478144, 078566754, 019729901
• Recalling Firm/ Manufacturer: MicroPort Orthopedics Inc.; 5677 Airline Rd; Arlington TN 38002-9501
• For Additional Information Contact: Rachael Wise; 901-867-4771
• Manufacturer Reason for Recall: Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
• FDA Determined Cause: Device Design
• Action: MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.
• Quantity in Commerce: 68,199 units
• Distribution: Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZO and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.