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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- 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 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2333-2020
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.