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  Class 2 Device Recall smith&hephew R3 THREE HOLE HA COATED 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-2334-2020
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 HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71331942
46MM 71331946
48MM 71331948
50MM 71331950
52MM 71331952
54MM 71331954
56MM 71331956
58MM 71331958
60MM 71331960
62MM 71331962
64MM 71331964
68MM 71331968
Orthopedic implant component.
Code Information 71331942, Lot Numbers: 18HM20692, 18EM07919  71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19DM17868, 19DM17872, 19EM20020, 18GM18521, 18JM14573, 19DM10929, 19DM10931, 19DM17866, 19DM17869, 19DM17871, 19EM20018  71331948, Lot Numbers: 18GM16878, 18JM08597, 18JM08598, 18JM08599, 18JM08600, 18MM01816, 18MM01825, 19BM08346, 19BM08353, 19BM08377, 19BM21631, 19BM21634, 19BM21642, 19CM00707, 19CM00729, 19DM17874, 19DM17875, 19DM17879, 19EM05719, 19EM05725, 19EM05727, 19EM05734, 19EM05735, 19EM05739, 19EM11935, 19EM19991, 19EM19995, 18GM16862, 19BM21637, 18GM16845, 18GM16860, 18GM16874, 18JM18993, 18DM20332, 18LM03848, 18MM01811, 18MM01818, 18LM03812, 18LM03851, 19BM08371, 19BM08373, 19BM21639, 19BM21643, 19CM00735, 19DM10935, 19DM17873, 19DM17878, 19EM11942, 19EM11943, 18LM17674, 19EM05738, 18GM04745, 18GM04750  71331950, Lot Numbers: 18FM17581, 18HM16477, 18HM16477A, 18HM16490, 18JM12754, 18JM12755, 18JM12814, 18KM08903, 18KM08903A, 18LM02612, 18LM02630, 19BM12905, 19CM15757, 19CM15761, 19CM15763, 19CM15765, 19DM06283, 19DM06289, 19DM06292, 19DM06486, 19DM10837, 19DM10842, 19DM10846, 19DM10851, 19EM11937, 19EM23519, 18FM17575, 18FM17585, 18GM01198, 18GM01198A, 18GM01210, 18GM01210A, 18GM04645, 18EM19483, 18EM19487, 18EM19523, 18GM01189, 18GM04664, 18HM16471, 18JM05420, 18JM12752, 18LM02613, 18LM11113, 19AM02040, 19AM02041, 19AM07778, 19CM01534, 19CM01543, 19CM15767, 19DM10838, 19DM10840, 19DM21848, 19EM11934, 19EM23498, 18EM19487A, 18GM01189A, 19CM15767A  71331952, Lot Numbers: 18FM02425, 18FM02426, 18FM02564, 18FM07528, 18GM00538, 18GM00538A, 18GM00584, 18GM00584A, 18GM09578, 18GM16948, 18HM23446, 18HM23446B, 18KM06737, 18KM26471, 18KM26480, 18LM02644, 18LM10385, 18LM13667, 18LM13690, 18LM13690A, 18LM18647, 18MM02055, 18MM02057, 18MM05762, 18MM05762A, 18MM05765, 18MM05765A, 19BM20198, 19BM20220, 19BM20220A, 19BM22774, 19BM22783, 19BM22788, 19CM22628, 19CM22632, 19CM22636, 19DM21882, 19DM21888, 19DM21905, 19DM21909, 19DM21914, 19EM05796, 19EM05808, 19EM17709, 18MM02039, 19BM20216, 19EM05799, 19BM20216A, 18FM11963, 18FM11965, 18FM11967, 18FM14864, 18FM14867, 18FM14868, 18GM00592, 18GM06508, 18GM06508A, 18GM06515, 18GM06533, 18GM06538, 18GM06541, 18GM06541A, 18GM06550, 18GM06555, 18EM13854, 18EM13857, 18FM02427, 18GM00587, 18GM07654, 18GM07666, 18HM23462, 18JM12782, 18JM12786, 18KM26470, 18LM02631, 18LM02666, 18LM13681, 18MM05787, 18MM05761, 18MM14820, 19AM02947, 19BM22771, 19DM21896, 19DM21899, 19DM21901, 19DM21904, 19DM21913, 19EM05797, 19EM05807, 19EM17702, 19EM17711, 18EM13857A, 18JM17200, 18JM07185, 18KM26470A, 18MM05761A, 19EM17702A, 18KM06740, 18KM06742  71331954, Lot Numbers: 18FM02432, 18FM02432B, 18FM02434, 18FM02434A, 18GM16959, 18GM16960, 18HM15320, 18HM15321, 18HM15321A, 18HM15321B, 18JM19411, 18LM02200, 18LM02228, 18LM02230, 18LM02255, 18LM10395, 19BM06530, 19BM06543, 19BM06623, 19BM06638, 19BM15988, 19BM16038, 19BM16039, 19BM16041, 19BM16043, 19BM16046, 19BM16048, 19BM20215, 19BM20222, 19BM20225, 19BM20227, 19BM20229, 19CM03984, 19CM04027, 19CM04033, 19CM04040, 19CM04045, 19CM04076, 19CM07039, 19CM07047, 19CM07054, 19CM07055, 19CM07055A, 19CM07056, 19CM07064, 19CM13919, 19CM19644, 19CM24281, 19DM07241, 19DM07247, 19DM07281, 19EM17724, 19EM20003, 18FM00161, 18FM16470, 18FM16474, 18FM16474A, 18FM16474B, 18FM16499, 18FM16548, 18FM21531, 18FM21557, 18EM17276, 18EM19555, 18EM19576, 18EM19577, 18FM01943, 18FM21566, 18LM02198, 18LM02201, 18LM02234, 18LM10394, 19BM06588, 19BM06662, 19BM20209, 19BM20210, 19BM20214, 19CM04002, 19CM04039, 19CM04043, 19CM13954, 19DM07256, 19DM15693, 19EM17720, 19EM23472, 18FM10239, 18HM15322A, 19CM04002A, 19CM04043A, 19DM15692A, 18KM01915, 18KM01929, 18KM01915A  71331956, Lot Numbers: 18EM20519, 18EM20521, 18GM06721, 18GM07670, 18GM16963, 18GM16965, 18HM04576, 18HM04581, 18HM04584, 18HM16084, 18LM02244, 18MM07586, 19CM03364, 19CM03365, 19CM03379, 19CM17413, 19DM07296, 19DM07297, 19DM07302, 19DM15697, 19DM15704, 19DM15710, 19DM29305, 19DM29332, 19DM29332A, 19EM09555, 19EM09558, 19EM20026, 18EM20515, 18GM00126, 18GM00127, 18GM00131, 18GM06708, 18GM06734, 18GM17029, 18GM17029A, 18JM04042, 18EM18364, 18GM00125, 18LM03826, 18LM03836, 18LM18627, 18MM01835, 19CM17414, 19DM07294, 19DM15696, 19DM15700, 19DM15706, 19DM15707, 19DM29300, 19EM09543, 19EM09556, 18LM18627A, 19CM18371, 18KM01961, 18KM01961A, 18LM09318A  71331958, Lot Numbers: 18GM09602, 18HM15999, 18HM21285, 18HM21291, 18HM21291A, 18KM00268, 18KM00268A, 18LM17980, 18LM17981, 19BM07155, 19BM07167, 19BM07168, 19BM07168, 19BM07170, 19BM07186, 19BM22782, 19BM22785, 19BM22786, 19BM22787, 19CM11398, 19CM11400, 19CM11411, 19CM11412, 19CM11421, 19DM10942, 19DM10943, 19DM10945, 19EM11290, 19EM11291, 18KM00271, 18KM00272, 18KM00263, 19BM07191, 18KM00271A, 18KM00272A, 18FM09877, 18FM12880, 18FM02438, 19BM07171, 19BM07192, 19BM07195, 19BM22784, 19CM11388, 19CM11394, 19DM10947, 19DM10949, 19EM23518, 18FM02438B, 19EM23518A  71331960, Lot Numbers: 18GM06745, 19CM17416, 19DM12906, 19DM12911, 19DM12912, 18EM23148, 18FM11142, 18FM11145, 18FM17591, 18FM17591A, 18FM17593, 18FM02384, 18FM02384A, 18HM10451, 18HM20601  71331962, Lot Numbers: 18JM02759, 19CM17431, 18FM11149, 18EM23155,  18JM01367, 18LM17982, 19EM05746   71331964, Lot Numbers: 19EM17714, 18FM02445, 18FM02445A  71331968, Lot Numbers: 19CM04528
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 4172 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.