Dynasty Liners recall
Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF…
Why was Dynasty Liners recalled?
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) metal acetabular liner systems.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF…
- Recalling firm
- MicroPort Orthopedics Inc.
- Quantity
- 6,250 units
- Distribution
- 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.
- Recall date
- December 7, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)