Smith & Nephew, Inc.: smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

Recall number

Z-2333-2020

Recalling firm

Smith & Nephew, Inc.

Product

smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

Status

Open, Classified

Initiated

2020-04-22

Posted

not on file

Terminated

not on file

Reason

A manufacturing error resulted in out of specification R3 Acetabular Shells

Root cause

Process control

Action

The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.

Quantity

6468 devices

Distribution

Worldwide

Lot, serial or model codes

71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391  71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19DM12898, 19DM12899  71335544, Lot Numbers: 18LM02189, 18LM02191, 18LM02192, 18MM08580, 18MM08582  71335546, Lot Numbers: 19AM10686, 19AM07909, 18MM08601, 18HM04443, 18HM04455, 18HM04461, 18HM04474, 18HM04483, 18HM04487, 18HM04488, 18HM04492, 18HM04495, 18HM04926, 18HM19845, 18HM19846, 18HM19848, 18HM19851, 18JM06297, 18JM06307, 18JM06308, 18KM17658, 18KM17659, 18KM17660, 18KM17662, 18MM08596, 18MM08602, 18MM08604, 18MM08607, 18MM08608, 18MM08609, 18MM08610, 18MM11254, 18MM11255, 19AM07907, 19AM07908, 19AM07916, 19AM07922, 18HM04443A, 18HM04455A, 18HM04488A, 18KM17662A, 19AM07922A, 18HM20664  71335548, Lot Numbers: 18LM19747, 19EM11800, 18LM13809, 18JM12746, 18KM09504, 18KM09498, 18KM09497, 19AM15831, 18LM19745, 18KM20266, 18MM14693, 18MM14703, 18MM14704, 18MM14697, 18LM13809A, 18MM01152, 18JM12746A, 18MM14703A, 18KM09502, 18LM13799, 18GM04646, 18GM04651, 18GM04658, 18GM04669, 18GM04677, 18GM04679, 18GM16200, 18GM16201, 18GM16203, 18GM16208, 18GM16210, 18GM16222, 18GM16240, 18GM18532, 18GM18541, 18GM18547, 18GM18567, 18GM18570, 18HM01688, 18HM01700, 18HM01709, 18HM01730, 18HM11151, 18HM11155, 18HM11167, 18HM11185, 18HM11192, 18HM11194, 18HM11207, 18HM19069, 18JM02729, 18JM12750, 18JM12751, 18JM12753, 18JM12760, 18JM12761, 18JM12765, 18JM12768, 18JM12771, 18KM09496, 18KM09501, 18KM09505, 18KM09510, 18KM13647, 18KM13648, 18KM13649, 18KM13650, 18KM13651, 18KM13652, 18KM13654, 18KM13655, 18KM20263, 18KM20264, 18LM00736, 18LM09824, 18LM09827, 18LM09828, 18LM09829, 18LM09835, 18LM09839, 18LM09852, 18LM09853, 18LM13765, 18LM13771, 18LM13774, 18LM13785, 18LM13786, 18LM13794, 18LM13797, 18LM13800, 18LM13814, 18LM19129, 18LM19138, 18LM19139, 18LM19141, 18LM19142, 18LM19749, 18LM19755, 18LM19756, 18LM19760, 18LM19762, 18LM19765, 18LM19771, 18MM02927, 18MM02933, 18MM02938, 18MM09564, 18MM11257, 18MM11260, 18MM11262, 18MM11265, 18MM11266, 18MM11268, 18MM11269, 18MM11275, 18MM14687, 18MM14691, 18MM14692, 18MM14700, 18MM14705, 18MM14708, 18MM14709, 19AM00787, 19AM15799, 19AM15807, 19AM15808, 19AM15834, 19AM15837, 19AM15839, 18GM16201A, 18GM18541A, 18GM18567A, 18HM01688A, 18HM11151A, 18HM11151B, 18JM03521, 18JM12750A, 18KM13649A, 18LM09852A, 18LM09852B, 18LM13771A, 18MM02358, 18MM07668, 18MM14700B, 18KM13650A, 18JM16121, 18KM09505A, 18KM20264A, 18KM13655A, 18MM14700A, 18LM19749A, 18KM20265A  71335550, Lot Numbers: 18MM14715, 18JM16421, 18MM11293, 18JM00837, 18MM11296, 18MM14694, 18MM14713, 18JM04490, 18JM04486, 18JM00844, 18MM14715A, 18JM16421A, 18MM14694A, 18GM06460, 18GM16291, 18GM16291A, 18KM24791, 18LM13776, 18GM06120, 18GM06191, 18GM06248, 18GM06259, 18GM06367, 18GM06374, 18GM06376, 18GM06381, 18GM06384, 18GM06446, 18GM06448, 18GM06454, 18GM06462, 18GM06481, 18GM16261, 18GM16275, 18GM16277, 18GM16281, 18GM18647, 18GM18648, 18GM19999, 18HM12250, 18HM12251, 18HM12291, 18HM12294, 18HM12308, 18HM12311, 18HM12313, 18HM12326, 18HM12367, 18HM12372, 18HM13026, 18HM13027, 18HM13031, 18HM14835, 18HM14852, 18HM14880, 18HM14881, 18HM15459, 18HM15461, 18HM15468, 18HM15484, 18HM15507, 18JM00831, 18JM00833, 18JM00834, 18JM00835, 18JM00838, 18JM04484, 18JM04485, 18JM04487, 18JM04497, 18JM04499, 18JM04897, 18JM04898, 18JM06646, 18KM24783, 18KM24811, 18LM02324, 18LM02325, 18LM02328, 18LM13789, 18MM11294, 18MM11303, 18MM11305, 18MM11309, 18MM14680, 18MM14683, 18MM14686, 18MM14688, 18MM14698, 18MM14701, 18MM14714, 19AM00774, 19AM00779, 19AM00780, 19AM00785, 19AM00789, 19AM00813, 19AM00823, 19AM00824, 19AM00827, 19AM00828, 19AM00830, 19AM00855, 18GM06259A, 18GM16279A, 18GM16281A, 18HM12251A, 18HM12311A, 18HM14852A, 18HM14880A, 18HM15459A, 18HM15507A, 18JM00831A, 18JM00833A, 18LM02325A, 19AM00779A, 18KM16035, 19AM00774A  71335552, Lot Numbers: 19DM00942, 18JM17685, 18KM20295, 18KM00810, 18LM00756, 18KM23741, 18LM00756A, 18GM07455, 18GM20389, 18JM12793, 18JM17688, 18KM06647, 18KM24186, 18LM00752, 18KM06668A, 19AM06152, 18GM20288.18GM20291, 18GM20296, 18GM20309, 18GM20331, 18GM20343, 18HM16439, 18HM16440, 18HM16443, 18HM16444, 18HM16452, 18HM16472, 18HM16489, 18HM16518, 18HM16522, 18HM16528, 18HM16550, 18HM16552, 18HM16553, 18HM16627, 18HM19802, 18HM19822, 18HM19826, 18HM19829, 18HM19835, 18HM19837, 18JM09331, 18JM09332, 18JM09333, 18JM09338, 18JM09339, 18JM09343, 18JM12790, 18JM12795, 18JM12831, 18JM12835, 18JM12858, 18JM12859, 18JM12861, 18JM12869, 18JM17671, 18JM17674, 18JM17683, 18JM17684, 18KM00789, 18KM00825, 18KM06654, 18KM13657, 18KM13659, 18KM13660, 18KM13665, 18KM13666, 18KM13667, 18KM13668, 18KM13685, 18KM13687, 18KM15744, 18KM15746, 18KM15747, 18KM15750, 18KM20307, 18KM20311, 18KM24813, 18KM24815, 18KM24816, 18KM24818, 18LM00739, 18LM02334, 18LM02335, 18LM17954, 18LM17955, 18LM17959, 18LM17965, 18LM17977, 19AM06094, 19AM06098, 19AM06100, 19AM06104, 19AM06111, 19AM06118, 19AM06122, 19AM06125, 19AM06127, 19AM06140, 19AM06141, 19AM06147, 19AM06150, 19AM13012, 19AM13015, 18GM20309A, 18HM16522A, 18HM16522B, 18HM16550A, 18HM16552A, 18HM19802A, 18HM19826A, 18HM19829A, 18HM19835A, 18JM10883, 18JM12859A, 18JM12861A, 18KM05958, 18LM00749A, 18LM02335A, 18LM09352, 18JM09338A, 18KM00790B, 18KM13667A, 18KM17682B, 19AM06104A, 18JM17664, 18JM17689A  71335554, Lot Numbers: 19FM00485, 18JM17714, 18KM26067, 18KM13702, 18KM13726, 18KM13722, 18JM13880, 18KM09537, 18JM13892, 18KM13709, 19AM18491, 18HM00801, 18HM04947, 18HM04957, 18HM04969, 18HM04973, 18HM05002, 18HM05005, 18HM05015, 18HM05019, 18HM05044, 18HM05065, 18HM19077, 18HM19078, 18HM19079, 18HM19082, 18HM19085, 18HM19086, 18HM19087, 18JM13881, 18JM17713, 18JM17715, 18JM17719, 18JM17730, 18KM03153, 18KM03154, 18KM03158, 18KM03161, 18KM09521, 18KM09523, 18KM09525, 18KM09526, 18KM09533, 18KM09538, 18KM09546, 18KM09548, 18KM13706, 18KM13713, 18KM13715, 18KM13719, 18KM13721, 18KM13725, 18KM13728, 18KM13729, 18KM13731, 18KM16116, 18KM16119, 18KM16120, 18KM16130, 18KM26035, 18KM26073, 18KM26078, 18LM05195, 18LM05196, 18LM05199, 18LM05208, 18LM10963, 18LM18558, 18LM18565, 18MM03110, 18MM03115, 18MM07166, 18MM07198, 18MM07208, 18MM07209, 18MM07211, 18MM07212, 18MM07217, 18MM07237, 18MM11338, 19AM07762, 19AM07769, 19AM07772, 19AM07773, 19AM07782, 19AM07783, 19AM18599, 18HM04957A, 18HM05044B, 18HM19085A, 18HM19087B, 18JM19382A, 18KM03154A, 18KM09538A, 18KM13715A, 18KM16119A, 18JM15275, 18JM18174, 18JM19382, 18KM09521A, 18KM13711A, 18KM16249, 18MM03110A, 18MM07198A, 18MM07209A, 18KM09546A  71335556, Lot Numbers: 18MM03107, 18MM03107A, 18MM12431, 18MM12437, 18LM13830, 18MM12440, 18JM16130, 18KM11135, 18JM16167, 18KM18727, 18MM15620, 18JM15974, 18JM15977, 18MM12430, 18JM16124, 18KM11175, 18KM04258, 18KM11126, 18JM15977A, 18LM00990, 18MM12440A, 18MM15620A, 18LM02892A, 18KM11177, 18JM18087, 18JM18087A, 18LM13844, 18LM13844A, 18MM12476, 19BM07521A, 19BM07553, 19BM07567, 18JM15968, 18JM16126, 18JM16153, 18JM16162, 18JM16171, 18JM18077, 18JM18080, 18JM18081, 18JM18086, 18JM18088, 18JM18095, 18JM18096, 18KM04256, 18KM11127, 18KM11129, 18KM11131, 18KM11158, 18KM11174, 18KM11176, 18KM11191, 18MM12432, 18MM12433, 18MM12438, 18MM12442, 18MM15598, 18MM15609, 18JM18077A, 18JM18077B, 18JM18086A, 18KM11174A, 19BM07512B, 18MM15609A, 18JM16171A, 19BM07512A  71335558, Lot Numbers: 19AM20555, 18LM09314, 18LM18593, 18LM18593A, 18JM01324, 19AM04787, 18LM09336, 18GM06066, 18GM16317, 18GM16321, 18GM16322, 18KM17664, 18KM17667, 18LM09315, 18LM09318, 18LM09319, 18LM09324, 18LM09325, 18LM09333, 18LM11687, 19am20552, 19AM20554, 19AM20559, 19AM20562, 19AM20563, 19AM20564, 19AM20577, 19AM20586, 19AM20595, 18GM16321A, 18GM16321B, 18GM16322A, 18KM17664A, 18LM09319A, 18KM17666B, 18LM09324A, 18LM09318A  71335560, Lot Numbers: 18JM01331, 18JM01331A, 18JM01330, 18JM01336, 18JM01336A, 18MM02930, 18MM02946A, 18LM09342, 18HM00793, 18JM01338, 18JM10162, 18JM10165, 18JM10166, 18JM10168, 18LM09340, 19BM12443, 18HM10463, 18HM10463A, 18HM20601

510(k) numbers

["K070756"]

PMA numbers

not on file

Product code

MBL

Firm FEI

1020279

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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