{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "149265", "product_res_number": "Z-0684-2017", "event_date_initiated": "2016-06-21", "event_date_posted": "2016-12-01", "recall_status": "Terminated", "event_date_terminated": "2017-07-01", "res_event_number": "75063", "product_code": "LZO", "k_numbers": [ "K100866" ], "product_description": "Dynasty Liners:\nREF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, \nFor use with the conserve metal head", "code_info": "Serial Numbers:  REF DLCOGA28 Seral Numbers: 1509498, 1509897, 107461555, 117476083, 127477625, 0411341968, 0611341969, 0901199714  REF DLCOGB32 Serial Numbers: 1428321, 027403682, 027403684, 027412214, 027412216, 027412218, 027412220, 027412222, 029789268, 048571448, 058605178, 068625411, 069837383, 078628910, 079859721, 087467577, 097474918, 097476396, 097477626, 098657540, 099905615, 099927666, 0101018635,  107480309, 107486655, 109968495, 0111248666, 0111254637, 117486656, 117501983, 119982392, 127504540, 127508429, 0211298850, 0211298851, 0401072608, 0501123237, 0601150684, 0711370347, 0711370832, 0711371855, 0711388872, 0801184970, 0801185465, 0901196484, 0901199209, 0901200444, 0901200704   REF DLCOGC36 Serial Numbers: 1389336, 1411596, 1412300, 1419309, 1421706, 1421872, 1421873, 1425040, 1425041, 1426635, 1441425, 1447128, 1448009, 017395680, 017396168, 017398843, 019752394, 027406078, 027406080, 027406549, 027408437, 027408506, 027412667, 029797073,038565179,  038571449, 039808007, 039823319, 039830311, 058576611, 059835277, 059843767, 059859139, 059869515, 067444752, 068608657, 069876613, 069885333, 077449136, 078628911, 078648401, 078648402, 086356142, 086364960, 087462096, 089905617, 089920491, 089924903, 097475888,  097475891, 097475892, 099932177, 099937595, 0101009548, 108705038, 109966090, 0111273375, 0111274786, 118728271, 119975127, 127506074, 127508430, 127514978, 129979634, 129990530, 0201044377, 0201044378, 0201048252, 0201071222, 0211301143, 0301068674, 0301084452, 0401085769, 0501125124, 0611343376, 0611343377, 0611365354, 0611366004, 0611366646, 0701164679, 0701165562, 0701178783, 0801190509, 0901189893, 0901191386, 0901200880, 0901201441, 0901201663   REF DLCOGD38 Serial Numbers: 1390011, 1422255, 1422256, 017395681, 017396169, 019751147, 019752153, 027404999, 027405000, 027408507, 027408521, 027411898, 027412100, 029793006, 038565180, 038571452, 039808008, 039823320, 039831045, 048576612, 049839752, 059846062, 059846677,  059868799, 059869517, 067445955, 067447299, 068608658, 069884531, 069888788, 077459273, 078628912, 078648403, 087464200, 087466701, 089901144, 089911489, 089922646, 096362335, 096374885, 097472362, 097474113, 097476397, 099932178, 099933792, 099937596, 0101038419, 0101038420, 107482012, 107486663, 108706223, 108716643, 108720178, 109941938, 109970863, 0111274868, 0111274869, 117486664, 117489826, 117501984, 118731716, 119980968, 127466702, 127504541, 127508431, 127512298, 128748672, 129990531, 0201062908, 0301062907, 0301067280, 0301067281, 0301081677, 0401096840, 0401098166, 0401109395, 0501127076, 0511344345, 0601147758, 0601148281, 0601148932, 0611344346, 0611346090, 0611346455, 0701172549, 0801192624, 0801193584, 0801193987, 0801194817, 0901192045, 0901203167, 0901206932, 1001206425, 1291016257, 1291016258, 1291019953, 1291019954, 08991148910   REF DLCOGE40 Serial Numbers: 1383898, 1422893, 017395849, 017396101, 017397513, 017398320, 019747416, 019749028, 019752393, 027404377, 027404964, 027406550, 027406551, 027407780, 039802355, 039809788, 039826200, 048571453, 048571454, 049834730, 049839160, 067436735, 069859138,  069868803, 069869518, 076357782, 077440680, 077453681, 078595478, 078595479, 078648404, 078648405, 079888789, 086362336, 087460119, 087460601, 089904051, 089920496, 096372317, 097472371, 097476398, 099931104, 099933793, 0101022064, 0101022065, 0101030547, 0101030548, 0101042594, 0101042595, 107482014, 107486667, 107486668, 107489825, 109941939, 109944905, 0111271873, 0111272250, 117489816, 117501985, 118722756, 118731717, 119980969, 127504542,  127508432, 127512297, 129990532, 0201057245, 0201064292, 0211295490, 0211301165, 0211302281, 0301064291, 0301081699, 0301083868, 0301084453, 0301095292, 0401095291, 0401096841, 0601165833, 0601165834, 0611361690, 0611361691, 0611364735, 0701170121, 0701170775, 0701171294, 0801194833, 0901194835, 0901207002, 0901208793, 0901208953   REF DLCOGF42 Serial Numbers: 1199809, 1366660, 1422894, 1423547, 017396170, 017397514, 017397515, 017398844, 027406424, 027406553, 027411519, 027411895, 027411896, 027413499, 029789333, 029789334, 029798203, 029809789, 029814314, 029819342, 037413500, 039819343, 049833519,  049839753, 058608659, 059846676, 059857910, 068595480, 069883241, 077449093, 078634682, 078634683, 078648406, 079860580, 079887540, 079894027, 086370088, 087462468, 089914628, 096372318, 097472373, 097476399, 099904052, 099931103, 0101022066, 0101030549, 0101030550, 107482016, 107486669, 107486670, 108705039, 108716644, 109922647, 109937597, 109943610, 109966091, 0111276618, 117496631, 117501986, 118728903, 118744506, 119972083, 127504543,  127509428, 127514975, 127514976, 128749026, 128751278, 129990533, 0201053787, 0201053788, 0201062909, 0201062910, 0201068675, 0211299901, 0301071223, 0301081700, 0301083869, 0401104095, 0401104096, 0501127409, 0611346456, 0701167385, 0701168088, 0701168230, 0701169430, 0701170051, 0711367085, 0901208997, 0901209918, 0901209977, 1101247355, 1101248443, 010103054910   REF DLCOGG44 Serial Numbers: 1383128, 1383366, 1392621, 1428789, 017396171, 017397398, 027404375, 027404965, 027406552, 027408531, 027412079, 027412080, 027412086, 029792981, 029793005, 029799054, 029799055, 038565181, 039828320, 039832455, 048571456, 048576613, 049828319,  049830312, 049839159, 057438911,058608660, 059855232, 059857911, 059860406, 059869519, 067445525, 069888790, 077447460, 077459517, 078608662, 078628913, 078648407, 078657546, 079894757, 087464126, 089915880, 089922080, 096362338, 096374886, 097476400, 097476401,  097480312, 098694868, 098706224, 099932179, 099934263, 099939751, 0101025139, 0101025144, 0101027410, 0101038421, 0101038422, 0101046891, 107481184, 107486653, 107487346, 108705037, 108716645, 108723278, 109966092, 117495711, 117495712, 117505591, 118730735, 118744505, 119975128, 119975129, 127504544, 127513338, 127518295, 127522391, 128747417, 128748669, 129998770, 129998777, 0201057246, 0201059716, 0201059717, 0201076758, 0211275710, 0301076757, 0301085876, 0301085877, 0301099035, 0301099036, 0311294091, 0311295489, 0401099037, 0401100077, 0401100078, 0401106374, 0401112729, 0411306527, 0411307069, 0601153393, 0601154045, 0601155591, 0801181073, 0801181695, 0801181920, 0801183924,  0801199319, 0901210490, 1001213377, 1001214138, 1101232813, 1201256582, 1201256583, 1201257832, 1291000319, 1291000321, 1291025140   REF DLCOGH48 Serial Numbers: 027403685, 027403686, 027410682, 027412223, 027412224, 027412225, 027412226, 078608663, 078648408, 078648409, 089904664, 097471988, 097476402, 097476542, 097477627, 0101042593, 107481183, 109967195, 0111277921, 117486671, 117496632, 127504545, 127508400, 127518297, 0201072609, 0401089450, 0601147117, 0901187425, 1101231165, 1291014716   REF DLCOGJ52 Serial Numbers: 099898795, 0101023111, 0201049895, 0201049896  REF DLCOGK56 Serial Numbers: 099898794, 0201023112, 0201049903, 0201052602, 0201052603", "firm_fei_number": "3010536692", "recalling_firm": "MicroPort Orthopedics Inc.", "address_1": "5677 Airline Rd", "city": "Arlington", "state": "TN", "postal_code": "38002-9501", "additional_info_contact": "Rachael Wise\n901-867-4771", "reason_for_recall": "Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)\nmetal acetabular liner systems.", "root_cause_description": "Device Design", "action": "MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com.\nFor questions regarding this recall call 901-867-4771.", "product_quantity": "6,250 units", "distribution_pattern": "Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.", "openfda": { "k_number": [ "K131884", "K223828", "K944601", "K122305", "K930788", "K170473", "K964395", "K061066", "K170089", "K181693", "K931617", "K131647", "K192827", "K010560", "K192126", "K920219", "K051858", "K250444", "K183532", "K112463", "K972637", "K933499", "K992144", "K261009", "K952418", "K213770", "K022985", "K122911", "K934457", "K892644", "K896669", "K173267", "K170339", "K131518", "K993043", "K933108", "K973681", "K930712", "K123392", "K203175", "K121439", "K083392", "K013935", "K201673", "K070554", "K953169", "K073337", "K093549", "K211548", "K211891", "K971752", "K163441", "K931189", "K042249", "K150576", "K961589", "K073567", "K041443", "K192416", "K190704", "K964249", "K150302", "K935913", "K040644", "K953690", "K032348", "K201047", "K051737", "K020713", "K922247", "K971426", "K043356", "K921181", "K061312", "K202730", "K161192", "K933942", "K183136", "K210263", "K203420", "K000432", "K935921", "K933567", "K053246", "K173898", "K223103", "K983404", "K992359", "K151739", "K192189", "K970846", "K945091", "K904028", "K152903", "K011836", "K250834", "K130128", "K920968", "K042992", "K240381", "K972361", "K912295", "K925682", "K140915", "K970200", "K121221", "K160895", "K242249", "K023901", "K122185", "K945090", "K132455", "K181744", "K212327", "K953925", "K945094", "K133381", "K140676", "K190890", "K980239", "K990261", "K130728", "K163577", "K002441", "K972228", "K123705", "K061564", "K173776", "K051738", "K221149", "K912641", "K112115", "K013106", "K923734", "K183141", "K042035", "K920577", "K203041", "K131458", "K955350", "K062997", "K193433", "K132435", "K143407", "K241767", "K152893", "K212069", "K251906", "K143096", "K052718", "K211567", "K932222", "K936256", "K141235", "K233476", "K923583", "K961727", "K032380", "K051411", "K171181", "K913420", "K213675", "K192024", "K941847", "K082525", "K150133", "K143509", "K935193", "K902712", "K082398", "K161840", "K090299", "K253171", "K161226", "K894904", "K050398", "K063279", "K191816", "K896850", "K890472", "K050556", "K980774", "K913633", "K151307", "K990183", "K220483", "K161830", "K981847", "K251292", "K142187", "K051741", "K945095", "K240452", "K931571", "K003413", "K121665", "K921224", "K141327", "K890060", "K931929", "K944209", "K051682", "K915310", "K082996", "K234025", "K070479", "K173380", "K202768", "K231925", "K201657", "K971721", "K052275", "K101451", "K170845", "K970490", "K993889", "K152919", "K022120", "K140975", "K973307", "K960588", "K042842", "K123924", "K181598", "K111046", "K123619", "K915641", "K063616", "K200007", "K093944", "K111193", "K885102", "K081973", "K011533", "K062684", "K060107", "K190344", "K192883", "K885069", "K040803", "K200112", "K891083", "K042091", "K082844", "K012091", "K905260", "K945089", "K973837", "K860275", "K932519", "K955877", "K141821", "K051588", "K151531", "K921111", "K953689", "K053587", "K964150", "K101472", "K902073", "K915396", "K183684", "K980473", "K243927", "K111936", "K180929", "K170359", "K260182", "K173794", "K162942", "K063816", "K200959", "K082991", "K191145", "K071082", "K943586", "K971414", "K192559", "K033944", "K070928", "K231109", "K921225", "K181061", "K991708", "K003923", "K010839", "K240528", "K180263", "K111572", "K213839", "K071830", "K211657", "K182705", "K241241", "K022555", "K072852", "K920145", "K260831", "K191632", "K944689", "K102080", "K071535", "K112682", "K243444", "K192352", "K000392", "K925345", "K953792", "K130634", "K181254", "K093846", "K183312", "K955386", "K972893", "K122296", "K894694", "K915184", "K102487", "K201471", "K181532", "K100008", "K905687", "K943774", "K030151", "K121392", "K120211", "K030373", "K991226", "K131952", "K991162", "K964357", "K161635", "K945093", "K123688", "K171156", "K962248", "K110101", "K243809", "K994184", "K952686", "K903976", "K243043", "K200196", "K964704", "K141653", "K953045", "K041940", "K914676", "K914237", "K111981", "K003379", "K172235", "K181171", "K120362", "K183365", "K083762", "K962101", "K052787", "K062748", "K992235", "K072656", "K991952", "K932935", "K013989", "K993874", "K240834", "K980081", "K970675", "K151902", "K182462", "K965002", "K123434", "K160289", "K172467", "K946026", "K182321", "K232371", "K941942", "K143739", "K001449", "K915222", "K203167", "K110087", "K243029", "K981201", "K971409", "K250450", 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"K953688", "K902074", "K844906", "K130376", "K093736", "K003274", "K193545", "K250571", "K081860", "K003316", "K131684", "K192660", "K190834", "K192683", "K895399", "K093991", "K012918", "K191831", "K970346", "K933275", "K942330", "K933203", "K222296", "K120531", "K201951", "K130899", "K961921", "K073102", "K912985", "K931572", "K103233", "K130343", "K130167", "K243466", "K973261", "K052237", "K923808", "K083312", "K252401", "K060577", "K905739", "K040734", "K910547", "K920756", "K260037", "K121011", "K181491", "K934694", "K150062", "K945096", "K925512", "K243021", "K140674", "K981302" ], "registration_number": [ "", "1020279", "3003791208", "3002806535", "3005551626", "3012392319", "2134285", "3006395932", "3010041693", "1000577893", "3002807315", "3012119238", "3011189525", "1531174", "3002807112", "1822565", "3030412764", "3010097171", "9610612", "1828288", "3009973505", "1218882", "3013055499", "1423662", "1047843", "3014833750", "9613350", "3007120646", "1644408", "3010314800", 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