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  Class 2 Device Recall smith&hephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL see related information
Date Initiated by Firm April 22, 2020
Create Date June 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-2333-2020
Recall Event ID 85637
510(K)Number K070756  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
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.
Code Information 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  
Recalling Firm/
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
Manufacturer Reason
for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
FDA Determined
Cause 2
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 in Commerce 6468 devices
Distribution Worldwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBL and Original Applicant = SMITH & NEPHEW, INC.