{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150044", "product_res_number": "Z-0351-2017", "event_date_initiated": "2016-08-29", "event_date_created": "2016-11-03", "recall_status": "Terminated", "event_date_terminated": "2019-08-16", "res_event_number": "75283", "product_code": "KWY", "k_numbers": [ "K023743" ], "product_description": "TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, \nREF NUMBERS: \n71324038, 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", "code_info": "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 \t   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 \t   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\t   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 \t  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 \t 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\t  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\t  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\t  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\t  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\t  REF NUMBER 71325052 Serial Numbers:  13LM03432, 13LM10117, 14AM16995, 14AM23119, 14BM10278, 13LM03434A, 14AM05537, 14AM17000, 14AM23124\t  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\t  REF NUMBER 71325057 Serial Numbers:  14BM00722, 14BM00722A  REF NUMBER 71372047 Serial Numbers:  13LM05789", "firm_fei_number": "1020279", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "1450 E Brooks Rd", "city": "Memphis", "state": "TN", "postal_code": "38116-1804", "additional_info_contact": "Joe Metzger\n978-749-1330", "reason_for_recall": "Some Bipolar shells were manufactured with an out of specification retainer groove.", "root_cause_description": "Process control", "action": "The firm initiated their recall by FedEx and Email on 08/29/2016 to hospitals and distributors and requested the return of any in stock product. International consignees were notified by Email on 08/29/2016. Additionally, the firm notified the US physician of the issue by overnight letter on 09/08/2016.", "product_quantity": "5806 units", "distribution_pattern": "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", "openfda": { "k_number": [ "K220492", "K945518", "K100151", "K183114", "K925420", "K904383", "K223441", "K961793", "K934159", "K862057", "K132539", "K940743", "K862460", "K931655", "K192236", "K152439", "K896257", "K981238", "K082468", "K050966", "K970284", "K963885", "K953977", "K982447", "K926387", "K884658", "K913632", "K062693", "K003363", "K881289", "K170072", "K131354", "K060707", "K173455", "K823726", "K855231", "K100761", "K810062", "K101670", "K023743", "K013211", "K900051", "K050269", "K091967", "K080647", "K010081", "K014072", "K781735", "K893872", "K945793", "K833991", "K953510", "K191569", "K980801", "K962448", "K925536", "K982389", "K143113", "K200709", "K833175", "K082705", "K123991", "K823482", "K925897", "K180130", "K191297", "K941534", "K833404", "K163081", "K893959", "K842344", "K221794", "K791823", "K873815", "K895120", "K861105", "K991990", "K112019", "K080979", "K243634", "K970447", "K944132", "K872019", "K040947", "K861566", "K922560", "K253357", "K191016", "K905370", "K873514", "K231526", "K982812", "K052990", "K896266", "K925153", "K121509", "K853795", "K960643", "K812672" ], "registration_number": [ "1038671", "3008812251", "3008544874", "1644408", "3003061090", "3020155054", "1220477", "3010163695", "3013055499", "3007120646", "2244478", "3008021110", "3005718816", "9614841", "3004126422", "3014302784", "3002807310", "3011170410", "3012130008", "1649518", "3009732568", "3007200272", "3002807112", "3015542154", "3013014058", "1450662", "3005323511", "9610612", "3002807315", "3010206549", "3021566676", "3010173425", "9613369", "3002806470", "1531174", "2528981", "1833506", "1225838", "3006356043", "3008572101", "3008110533", "3011295718", "3005562917", "2249697", "3002907620", "3002807295", "3033509898", "1720929", "1828464", "2245304", "3013791180", "3006017180", "1226544", "1221763", "2032098", "3002807314", "1835251", "1645151", "3023852420", "3011683674", "3008102042", "1721676", "3010536692", "1722511", "3015207155", "3010537287", "3013186738", "1833986", "3003387384", "3003998208", "3004635447", "1834331", "1000547811", "3010386387", "1000577893", "3010363503", "3010009693", "3002498892", "1043653", "3004748528", "1529009", "3016438694", "3010097171", "3008262872", "3021008900", "3019807891", "3030412764", "1221053", "1057425", "8043792", "2648920", "9616671", "3013450937", "9610921", "3008868758", "3007311878", "3009973336", "3012275107", "3006809628", "3004153896", "3004641308", "1526534", "9614209", "3006946279", "9681642", "3009475821", "3013176080", "3015167917", "3002808022", "3009106092", "3010057495", "3006801265", "3010314800", "3005180920", "2133928", "8010916", "1833920", "3008556682", "9681465", "1643817", "3006406161", "1220246", "3012523063", "3004513872", "9610726", "3005913274", "3006849754", "3010220595", "3014644608", "3009756327", "3015516266", "3042508254", "1822565", "3009973505", "3015259876", "3020282716", "2246552", "3005551626", "3017397663", "1047843", "9617083", "3013302242", "3005061536", "3006001176", "3009760038", "1018470", "1835831", "3011277306", "1825034", "1424263", "3038503932", "1827096", "1000550978", "8044172", "3011461101", "3014170143", "1219655", "9616680", "1226188", "8010379", "3002806535", "3014763043", "3012725451", "3008534770", "3015398319", "2032521", "3009882462", "3006395932", "1835572", "2134285", "1020279", "3007740680", "3012392319", "3007366790", "3010123256", "3007913880", "2249615", "9616944", "3013194153", "3002806603", "3010178296", "3010287737", "3016438761", "3021386586", "3000236920", "3004142400", "3007353762", "3010041693", 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