—#181434

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.

FDA product code: MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070756
Affected lot / code info: 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

Why it was recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2020-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.