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FDAFDA · Food and drugs·Recall number Z-2334-2020

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.

Published June 17, 2020 · Recall initiated: April 22, 2020

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

A manufacturing error resulted in out of specification R3 Acetabular Shells

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Smith & Nephew, Inc.
Distributor
Worldwide
Lot
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, 19
Risk classification
Class II
Area (FDA)
device
Country
United States

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