Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021...

FDA Device Recall #Z-0687-2017 — Class III — June 21, 2016

Recall Summary

Recall Number Z-0687-2017
Classification Class III — Low risk
Date Initiated June 21, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MicroPort Orthopedics Inc.
Location Arlington, TN
Product Type Devices
Quantity 68,199 units

Product Description

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

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.

Distribution Pattern

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.

Lot / 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, 115286920, 125289072, 125292873, 125292874, 125296714, 016298245, 016299491, 016305133, 026310218, 026302361, 036308001, 036310217, 036310219, 056330392, 056332871, 056340026, 066341305, 066345324, 066345840, 066349354, 066351419, 066347958, 076355228, 086358036, 086361948, 086364974, 086363658, 086365168, 086365303, 086365799, 096369225, 096369764, 096370914, 096373192, 106372047, 106373450, 106373750, 106376026, 106374101, 106375107, 106375516, 106374211, 106374626, 106379225, 126379862, 126382348, 126380547, 126382347, 017391959, 017392726, 017392153, 017392740, 017394537, 017394749, 017394790, 017395033, 027402156, 027402314, 027402335, 027402455, 027405331, 027405332, 027405333, 027405334, 037405310, 037415064, 037406826, 037410509, 037410510, 037413443, 047416146, 047416209, 047417817, 047422967, 047421689, 047422273, 057422966, 057429972, 057429973, 057429974, 057430371, 057430372, 057431108, 067434231, 067436039, 067434567, 067437755, 077439334, 077445971, 087452736, 087457715, 087457721, 087459528, 087460715, 097459527, 097465290, 097471768, 107469754, 107472500, 107472438, 107474168, 107474402, 117480803, 117481329, 117481328, 117485442, 117485441, 018502149, 127492017, 018492016, 127489932, 018488353, 018502150, 018506877, 018503891, 038512202, 038519220, 038519221, 038502148, 038506878, 058529216, 048529219, 068555729, 068555730, 068555731, 068580393, 068580394, 068580395, 068599930, 068595148, 068595151, 078595153, 078599929, 078632856, 078632861, 088632857, 088632858, 088632859, 088632862, 088632860, 088632863, 098669020, 098669021, 098676878, 098676879, 098689059, 108676877, 108676876, 108706250, 108706251, 108706253, 128740267, 128740268, 128743157, 128743158, 128744184, 019744186, 019744185, 019748664, 019748667, 029752497, 029763677, 029803716, 029783710, 029784164, 029784163, 029789150, 039763678, 039805757, 039805758, 049830308, 059837881, 059837880, 059839749, 059843700, 059843702, 059843706, 059843704, 069859718, 079881860, 079867726, 079867727, 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, 036307858, 036318686, 036319094, 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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, 065238423, 065223329, 075223310, 095249033, 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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, 036318685, 036319017, 036319092, 066341307, 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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, 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Other Recalls from MicroPort Orthopedics Inc.

Recall # Classification Product Date
Z-1133-2026 Class II Brand Name: MicroPort Product Name: HIPTURN FE... Dec 19, 2025
Z-0699-2025 Class II EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZ... Oct 29, 2024
Z-2244-2024 Class II EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-p... May 3, 2024
Z-0275-2023 Class II EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ET... Oct 28, 2022
Z-0276-2023 Class II EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETP... Oct 28, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.