CLASS II ONGOING Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

R3 Three Hole Hemispherical Stiktite Coated Shell recalled

Smith & Nephew is recalling smith&nephew R3 Three Hole Hemispherical Stiktite Coated Shell. The recall was initiated on 22 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes71335540, 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

Quantity recalled6468 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2333-2020
FDA event ID: 85637
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Ongoing
Recall initiated: 22 Apr 2020
FDA classified: 9 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Hip & Knee Implants

Timeline

22 Apr 2020	Recall initiated by company
9 Jun 2020	Classified by FDA	+48 days
17 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A manufacturing error resulted in out of specification R3 Acetabular Shells

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Worldwide

Questions about this recall

Is R3 Three Hole Hemispherical Stiktite Coated Shell recalled?

Yes. Smith & Nephew recalled R3 Three Hole Hemispherical Stiktite Coated Shell on 22 Apr 2020. The recall is Class II and its status is Ongoing. Recall number Z-2333-2020.

Why was it recalled?

A manufacturing error resulted in out of specification R3 Acetabular Shells

Which lots are affected?

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

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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28 May 2025Device	CLASS II	Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
11 Dec 2024Device	CLASS II	Bioraptor Suture Anchors recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
13 Nov 2024Device	CLASS II	Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide