Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0351-2017)

TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047

Class II

Some Bipolar shells were manufactured with an out of specification retainer groove.

REF NUMBER 71324038 Serial Numbers: 13LM19426, 13LM19431, 14BM10263, 14BM10264 REF NUMBER 71324039 Serial Numbers: 13LM16207, 14AM08786, 14AM08786A REF NUMBER 71324040 Serial Numbers: 13LM12963, 13LM17120, 13MM18005, 14BM00728, 14BM10265A, 14BM16804, 13LM12964, 13MM18000, 14AM02711, 14BM00729, 14BM10266, 14BM16815, 13LM16210, 13MM18001, 14AM12034, 14BM01149, 14BM10266A, 13LM17118, 13MM18003, 14BM00727, 14BM10265, 14BM10268 REF NUMBER 71324041 Serial Numbers: 13LM12870, 13LM12880, 13MM18006, 14AM02713, 14AM12043, 14BM20733, 13LM12874, 13LM17121, 14AM02712, 14AM02714, 14BM00730 REF NUMBER 71324042 Serial Numbers: 13LM14881, 13MM02907, 13MM09996, 14BM00737, 14BM06960, 14BM16819A, 13LM14881A, 13MM02907A, 13MM09998, 14BM01141, 14BM06961, 14BM16820, 13LM14883, 13MM02908, 13MM09998A, 14BM01144, 14BM14307, 14BM16822, 13LM14883A, 13MM02909, 14AM12035, 14BM03060, 14BM14318, 14BM16825, 13LM14885, 13MM02910, 14AM12042, 14BM03110, 14BM16819 REF NUMBER 71324043 Serial Numbers: 13LM17122, 13LM19387, 13MM04114, 13MM04124, 13MM08123, 14AM12038, 13LM17123, 13LM19387A, 13MM04116, 13MM04126, 13MM08124, 14AM12038A, 13LM17123A, 13LM19389, 13MM04117, 13MM04126A, 13MM08124A, 14BM00775, 13LM17124, 13MM04108, 13MM04118, 13MM08116, 13MM08126, 14BM00775A, 13LM17125, 13MM04108A, 13MM04120, 13MM08116A, 13MM09999, 14BM01146, 13LM17126, 13MM04111, 13MM04123, 13MM08118, 13MM10001, 13LM19386, 13MM04112, 13MM04123A, 13MM08121, 14AM07555 REF NUMBER 71324044 Serial Numbers: 13KM22764, 13LM00822, 13LM00828, 13LM00831, 13LM00899, 13LM00900, 13LM06362, 13LM06363, 13LM06364, 13LM17127, 13LM17128, 13LM17128A, 13LM17129, 13LM17132, 13LM17133, 13LM17134, 13LM17136, 13LM17157, 13LM17160, 13MM04130, 13MM04130A, 13MM04132, 13MM04132A, 13MM04134, 13MM04135, 13MM04136, 13MM04139, 13MM04139A, 13MM04141, 13MM10009, 14AM15528, 14AM15529, 14AM21699, 14AM21701, 14AM21704, 14AM21707, 14AM24082, 14AM24083, 14AM24084, 14AM24084A, 14AM24085, 14AM24086, 14AM24087, 14AM24088, 14AM24091, 14AM24098, 14BM04004, 14BM04014, 14BM04015, 14BM04017, 14BM04019, 14BM04021, 14BM06965, 14BM06966, 14BM06967, 14BM06970, 14BM06971, 14BM06973, 14BM06975, 14BM06975A, 14BM06977, 14BM06977A, 14BM08966, 14BM08970, 14BM08971, 14BM12189, 14BM12192, 14BM12194, 14BM12195, 14BM14321, 14BM14805, 14DM11275 REF NUMBER 71324045 Serial Numbers: 13KM24095, 13KM24095A, 13KM24097, 13KM24099, 13LM04114, 13LM06366, 13LM17165, 13LM17169, 13LM17169A, 13MM04143, 14AM00467, 14AM00469, 14AM00474, 14AM00478, 14AM00485, 14AM00485A, 14AM00490, 14AM00490A, 14AM02715, 14AM02716, 14AM02717, 14AM02717A, 14AM02718, 14AM02718A, 14AM12041, 14AM16532, 14AM24089, 14AM24090, 14BM03989, 14BM13827, 14BM17706, 14BM17710, 14BM17712, 14BM17712A, 14BM17713 REF NUMBER 71324046 Serial Numbers: 13KM24091, 13LM15742, 13MM13862, 14AM02708A, 14AM24102A, 14BM04026, 13KM24092, 13LM15743, 13MM13863, 14AM02709, 14AM24103, 14BM14323, 13KM24093, 13LM15743A, 13MM13864, 14AM16514, 14AM24103A, 14BM14324, 13LM04070, 13LM15745, 13MM13865, 14AM16514A, 14AM24108, 14BM14324A, 13LM04072, 13LM15745A, 13MM13866, 14AM16515, 14AM24109, 14BM14327, 13LM04073, 13LM15746, 13MM13867, 14AM16520, 14BM00835, 14BM19649, 13LM11741, 13LM15747, 14AM02704, 14AM16521, 14BM01154, 14BM20553, 13LM11741A, 13MM13857, 14AM02705, 14AM16522, 14BM01157, 13LM15736, 13MM13858, 14AM02706, 14AM16524, 14BM04024, 13LM15741, 13MM13859, 14AM02707, 14AM24101, 14BM04024A, 13LM15741A, 13MM13860, 14AM02708, 14AM24102, 14BM04025 REF NUMBER 71324047 Serial Numbers: 13LM00813, 13LM14897, 13MM14128, 14AM00453, 14AM16528, 14BM14334, 13LM01891, 13LM14899, 13MM14134, 14AM16526, 14BM14332, 13LM01892, 13MM13677, 13MM18008, 14AM16526A, 14BM14333, 13LM14895, 13MM14126, 13MM18008A, 14AM16526B, 14BM14333A REF NUMBER 71324048 Serial Numbers: 13LM01893, 13LM14908, 13MM13695A, 14AM00586B, 14AM16531, 14BM08987, 13LM01894, 13LM14909, 14AM00527, 14AM12010, 14BM03036, 14BM08988, 13LM01895, 13LM14910, 14AM00532, 14AM12012, 14BM03036A, 14BM08988A, 13LM14903, 13LM14910A, 14AM00541, 14AM12014, 14BM08979, 14BM14335, 13LM14905, 13MM13470, 14AM00562, 14AM12014A, 14BM08979A, 14BM14336, 13LM14905A, 13MM13691, 14AM00563, 14AM12015, 14BM08979B, 14BM14337, 13LM14906, 13MM13692, 14AM00567, 14AM16529, 14BM08980, 14BM14338, 13LM14906A, 13MM13695, 14AM00586, 14AM16530, 14BM08983, 14BM14339 REF NUMBER 71324049 Serial Numbers: 13MM10141, 13MM10147, 13MM10150, 13MM10160, 14BM15222, 13MM10143, 13MM10147A, 13MM10157, 13MM13712, 14BM15222A, 13MM10143A, 13MM10149, 13MM10159, 14BM15206 REF NUMBER 71324050 Serial Numbers: 13KM20614A, 13LM07412A, 14AM00595, 14AM12027A, 14BM03022A, 14BM15227, 13KM20615, 13LM07413A, 14AM00599, 14AM12029, 14BM03022B, 14BM15243, 13LM06367, 13LM07414, 14AM00603, 14AM12030, 14BM03023, 14BM15246, 13LM06370, 13LM07414B, 14AM06642, 14BM03018, 14BM03023A, 14BM15247, 13LM06371, 13LM07415, 14AM06643, 14BM03021, 14BM03025, 13LM06371A, 13LM07415A, 14AM06644, 14BM03021A, 14BM03025A, 13LM07412, 14AM00593, 14AM12027, 14BM03022, 14BM03026 REF NUMBER 71324051 Serial Numbers: 13LM07416, 13LM07418, 14AM02685, 14BM15248, 14BM15249A, 14BM17717, 13LM07417, 14AM02684, 14AM02685A, 14BM15249, 14BM15250, REF NUMBER 71324052 Serial Numbers: 13LM07419, 13LM07425, 13MM13701A, 14BM03065, 14BM11515, 14BM19330, 13LM07419B, 13MM10273, 14AM02686, 14BM03066, 14BM11526, 14CM21388, 13LM07420B, 13MM13698, 14AM02687, 14BM03067, 14BM19328, 13LM07420D, 13MM13700, 14AM02688, 14BM03119, 14BM19328A, 13LM07422, 13MM13700A, 14AM02689, 14BM11513, 14BM19328B, 13LM07424, 13MM13701, 14AM21904, 14BM11514, 14BM19329 REF NUMBER 71324053 Serial Numbers: 13LM04205, 13LM04207, 13LM04207A, 13LM04213, 14AM21697, 14BM17728 REF NUMBER 71324054 Serial Numbers: 13LM04201, 13LM14911, 14AM06637, 14BM10269, 14BM10272, 14BM11528, 13LM04204, 13LM14911A, 14AM06638, 14BM10269A, 14BM11527, 14BM11530 REF NUMBER 71324055 Serial Numbers: 13KM22761A, 13KM22761C, 13LM04199A, 13MM13714, 14BM15251, 13KM22761B, 13KM22762, 13MM10153, 14BM03126 REF NUMBER 71324057 Serial Numbers: 13LM04196, 14AM12031, 14AM12032, 14BM19299 REF NUMBER 71324059 Serial Numbers: 14BM00731, 14BM00731A REF NUMBER 71325039 Serial Numbers: 13LM14010, 13MM15827A, 14AM14596, 14AM18791, 13MM15827, 14AM03055, 14AM14596A, 14BM18438 REF NUMBER 71325040 Serial Numbers: 13LM11504, 13MM09291, 14AM05485, 14BM00723, 14BM05787, 13LM12921, 14AM03739, 14AM16892, 14BM00725, 14BM05787A REF NUMBER 71325041 Serial Numbers: 13LM12928, 13LM14007A, 13MM01327, 14AM09899, 14AM16953, 13LM12930, 13MM01324, 14AM05489, 14AM15512, 14BM05789, 13LM14007, 13MM01324A, 14AM05492, 14AM15514 REF NUMBER 71325042 Serial Numbers: 13LM05334, 13LM05339, 13LM12934, 14AM05499, 14AM15509, 14BM05790, 13LM05335, 13LM05341, 13LM13889, 14AM05500, 14AM15510, 14BM05791, 13LM05337, 13LM12933, 13LM13891, 14AM09891, 14AM16954, 14BM05792, 13LM05338, 13LM12933A, 14AM05498, 14AM09895, 14AM23046, 14BM17724 REF NUMBER 71325043 Serial Numbers: 13LM10125, 13LM10151, 14AM05505A, 14AM15505A, 14AM23041, 14BM17626, 13LM10126, 13LM14912, 14AM09900, 14AM15506, 14AM23044, 13LM10127, 14AM03759, 14AM09902, 14AM15507, 14BM05794, 13LM10128, 14AM05501, 14AM15503, 14AM16955, 14BM10399, 13LM10129, 14AM05502, 14AM15503A, 14AM16955A, 14BM11540, 13LM10130, 14AM05505, 14AM15504, 14AM16957, 14BM11540A REF NUMBER 71325044 Serial Numbers: 13KM09768, 13MM08132, 13MM08136A, 14AM13561A, 14AM16967, 14AM23022, 13LM03438, 13MM08133, 13MM08137, 14AM13561B, 14AM16968, 14BM05795, 13LM03439, 13MM08134, 14AM13557, 14AM16960, 14AM16969, 14BM10259, 13LM03443, 13MM08135, 14AM13560, 14AM16961, 14AM16971, 14BM10260, 13LM03444, 13MM08135A, 14AM13560A, 14AM16963, 14AM16971A, 13MM08130, 13MM08136, 14AM13561, 14AM16965, 14AM23010 REF NUMBER 71325045 Serial Numbers: 13LM05344, 13LM19404A, 13MM08035, 14AM13564, 14AM16972, 14BM03983, 13LM19400, 13LM19407, 14AM09995, 14AM16536, 14AM16973, 14BM03988, 13LM19402, 13MM08033, 14AM09996, 14AM16537, 14AM16973A, 14BM03988A, 13LM19403, 13MM08034, 14AM13563, 14AM16537A, 14AM16974, 14BM05796, 13LM19404, 13MM08034A, 14AM13563A, 14AM16539, 14BM03981 REF NUMBER 71325046 Serial Numbers: 13LM05346, 13LM19451, 13MM09247, 14AM16534, 14AM23073, 14BM11534, 13LM14918, 13MM01341, 14AM09997, 14AM16975, 14AM23073A, 14BM11536, 13LM14922, 13MM09245, 14AM09998, 14AM16976, 14AM23076, 13LM19449, 13MM09245A, 14AM09999, 14AM16976A, 14AM23076A REF NUMBER 71325047 Serial Numbers: 13LM13911, 14AM03760, 14AM12055, 14AM13566A, 14AM23079, 13LM13912, 14AM12045, 14AM12062, 14AM15499, 14BM11537, 13LM13912A, 14AM12050, 14AM13566, 14AM15501 REF NUMBER 71325048 Serial Numbers: 13LM13988, 13MM09279, 14AM05514A, 14AM16982, 14BM11532, 13LM13988A, 13MM09279A, 14AM16979, 14AM23081, 14BM11533, 13LM14006, 14AM05512, 14AM16979A, 14AM23084, 14BM11533A, 13LM19458, 14AM05514, 14AM16980, 14AM23084A, 14CM06925 REF NUMBER 71325049 Serial Numbers: 13LM05330, 13LM05332A, 13MM09289, 14AM08792, 14AM16986, 13LM05330A, 13LM13904, 13MM09290, 14AM16984, 14AM23086, 13LM05332, 13LM13904A, 14AM08791, 14AM16985, 14AM23089 REF NUMBER 71325050 Serial Numbers: 13LM03426, 13LM03431, 13LM13897A, 14AM16990, 14BM10261, 13LM03426A, 13LM05329, 13LM13897B, 14AM16990A, 14BM10262, 13LM03430, 13LM08816, 14AM03765, 14AM16991, 14BM10262A, 13LM03430A, 13LM13897, 14AM12052, 14AM17003 REF NUMBER 71325051 Serial Numbers: 13LM10120, 13LM10122, 14AM03766, 14AM15473, 14AM16993A, 14AM23129, 13LM10121, 13LM17626, 14AM05511, 14AM16993, 14AM23128, 14BM03984 REF NUMBER 71325052 Serial Numbers: 13LM03432, 13LM10117, 14AM16995, 14AM23119, 14BM10278, 13LM03434A, 14AM05537, 14AM17000, 14AM23124 REF NUMBER 71325053 Serial Numbers: 13LM12937, 14AM05474A, 14AM15517, 14BM11539A, 14BM11539D, 13MM00436, 14AM05476, 14AM15517A, 14BM11539B, 14AM05474, 14AM15516, 14BM11539, 14BM11539C REF NUMBER 71325054 Serial Numbers: 13LM03435, 14AM03757, 14AM16997, 14BM15265 REF NUMBER 71325055 Serial Numbers: 13LM12939, 13MM01365A, 14AM15441, 14BM10280, 13MM01365, 14AM15440, 14AM23118 REF NUMBER 71325057 Serial Numbers: 14BM00722, 14BM00722A REF NUMBER 71372047 Serial Numbers: 13LM05789

Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates

Voluntary: Firm initiated