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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smith & Nephew, Inc.
- Reason for Recall:
- A manufacturing error resulted in out of specification R3 Acetabular Shells
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2334-2020
Related Recalls
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
The Bipolar assembly contains an oversized Retainer Ring.