Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26...
FDA Device Recall #Z-0689-2017 — Class III — June 21, 2016
Recall Summary
| Recall Number | Z-0689-2017 |
| Classification | Class III — Low risk |
| Date Initiated | June 21, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MicroPort Orthopedics Inc. |
| Location | Arlington, TN |
| Product Type | Devices |
| Quantity | 108,362 units |
Product Description
Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404, 38014435, 38014600, 38014604, 38014635, 38014800, 38014804, 38014835, 38015000, 38015004, 38015035, 38015200, 38015204, 38015235, 38015400, 38015404, 38015435, 38015600, 38015604, 38015635, 38AC3600, 38AC3800, 38AC4000, 38AC4200, 38AC4400, 38AC4600, 38AC4800, 38AC5000, 38AC5200, 38AC5400, 38AC5600, 38AM3600, 38AM3604, 38AM3635, 38AM3800, 38AM3804, 38AM3835, 38AM4000, 38AM4004, 38AM4035, 38AM4200, 38AM4204, 38AM4235, 38AM4400, 38AM4404, 38AM4435, 38AM4600, 38AM4604, 38AM4635, 38AM4800, 38AM4804, 38AM4835, 38AM5000, 38AM5004, 38AM5035, 38AM5200, 38AM5204, 38AM5235, 38AM5400, 38AM5404, 38AM5435, 38AM5600, 38AM5604, 38AM5635, PL38HM4400, PL38HM4404, PL38HM4435, PL38HM4600, PL38HM4604, PL38HM4635, PL38HM4800, PL38HM4804, PL38HM4835, PL38HM5000, PL38HM5004, PL38HM5035, PL38HM5200, PL38HM5204, PL38HM5235
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) metal acetabular liner systems.
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.
Lot / Code Information
Transcend REF 26000017 Serial Numbers: 1392035, 1394262, 1403269, 1404128, 1405348, 1406868, 1416193, 1416410, 416916, 1417966, 1421701, 1424398, 1427395, 1429561, 1432313, 1432727, 1435174, 1436773, 1437714, 1444931, 1463853, 1469307, 1469928, 1472480, 1473802, 1475742, 1483472, 1485543, 1485544, 1491257, 1495872, 1495873, 1497225, 1497226, 1497227, 1497228, 1502990, 1502991, 1504262, 1509260, 1509261, 1513940, 1513941, 1516239, 1519175, 1523291, 1527824, 1527825, 1532934, 1532935, 1532936, 1534591, 1544282, 1544283, 1544284, 1548096, 1548097, 1553540, 1553541, 1555918, 1555919, 1555920, 1564763, 1564764, 1567221, 1567222, 1567223, 1567765, 1574244, 1574245, 1574246, 1586932, 1586937, 1587450, 1587451, 1587452, 1594879, 1602102, 1602103, 1607364, 1607365, 1612602, 1616179, 1618966, 1618967, 1636635, 1638711, 1638712, 1643938, 1643939, 1647724, 1647725, 1648020, 1648021, 1654503, 1654504, 1657402, 1659130, 02465512, 02465513, 02469868, 03211703, 03211704, 03217505, 04479690, 06345789, 06483517, 06485500, 10352345, 11230587, 12358929, 12360234, 015158577, 016305137, 017385213, 018513341, 018523879, 018523880, 026316750, 027411850, 035191682, 035191683, 037414681, 037417015, 037420473, 038542236, 038548053, 046336505, 047426887, 047431539, 049843313, 056332870, 057433631, 058595417, 058595419, 065229799, 066343506, 067442240, 067446422, 068595420, 068595422, 069876963, 069876964, 075255286, 076360909, 077450626, 077455529, 085258369, 086369486, 086370994, 087460631, 087462039, 087469136, 088672406, 088672407, 088672408, 094104768, 096372363, 097480313, 097481152, 098694953, 098703737, 0101010115, 104104769, 105275570, 107483300, 107489009, 108716008, 109938837, 0111278886, 114131980, 114135078, 115290207, 118738338, 118741128, 119978431, 119994169, 125301489, 127496633, 127513339, 127513340, 128739171, 0201069672, 0201069673, 0201069674, 0211297628, 0211299902, 0301089722, 0301091275, 0301096837, 0311323467, 0311325664, 0311330683, 0311332184, 0401100071, 0401100107, 0401101147, 0411332564, 0411344347, 0411344348, 0511345415, 0601148840, 0601148931, 0611371879, 0701179525, 0701179670, 0711370852, 0711371390, 0711381247, 0711390646, 0901193308, 0901199757, 0901200139, 0901200600, 1001235128, 1001236308, 1101235029, 1101254636, 1101254709, 1101258592, 1101258593, 1101259125, 1201266195, 1201267539, 1201267540, 16439381652115 REF 26000018 Serial Numbers: 1389320, 1392131, 1394263, 1397119, 1400719, 1403531, 1406742, 1406967, 1412519, 1413648, 1413871, 1414179, 1414180, 1414896, 1414897, 1416201, 1416673, 1420483, 1430442, 1430443, 1431008, 1431451, 1431452, 1432728, 1435175, 1436383, 1436772, 1439333, 1444099, 1444102, 1444240, 1446872, 1448610, 1457129, 1460999, 1461001, 1466074, 1466075, 1469308, 1470078, 1471689, 1472302, 1474005, 1474006, 1475023, 1476007, 1476100, 1476101, 1477377, 1481146, 1481147, 1483466, 1483467, 1484425, 1484426, 1484767, 1484768, 1487090, 1487091, 1487092, 1489845, 1491259, 1495973, 1495974, 1497250, 1497251, 1498778, 1498779, 1500626, 1501326, 1503278, 1503279, 1503728, 1504263, 1507991, 1507992, 1509298, 1509300, 1511955, 1511956, 1511957, 1513942, 1516240, 1516241, 1516967, 1516968, 1519176, 1523292, 1526399, 1526400, 1526401, 1527827, 1532937, 1532938, 1532939, 1534586, 1534587, 1534588, 1541698, 1541699, 1542310, 1542311, 1542312, 1542313, 1548271, 1548272, 1548797, 1551551, 1553113, 1553114, 1553115, 1554787, 1554788, 1554789, 1561459, 1561460, 1561461, 1561462, 1566790, 1566791, 1567219, 1567220, 1568431, 1568432, 1568433, 1568959, 1569900, 1586629, 1586630, 1587101, 1587102, 1587103, 1587104, 1590827, 1592379, 1592822, 1593585, 1598909, 1598910, 1602100, 1602101, 1607260, 1607262, 1610138, 1612604, 1615574, 1615928, 1618517, 1618518, 1618519, 1622629, 1622630, 1632305, 1632306, 1634568, 1634569, 1638713, 1638714, 1638715, 1643940, 1643941, 1644912, 1646062, 1646063, 1646064, 1647396, 1647397, 1652569, 1652570, 1654233, 1654234, 1656995, 1656996, 1656997, 1656998, 02469869, 03211913, 03217506, 03474751, 04479691, 06224414, 06225575, 06337219, 06341526, 06489178, 07225649, 07489910, 08349027, 08489909, 09226596, 09226597, 10356227, 11229552, 11357108, 12234610, 12357109, 12358930, 015162548, 016305918, 016306451, 017394609, 017400397, 017403582, 018513343, 018513344, 018521820, 018523881, 018523882, 019738626, 027406270, 027410096, 028542237, 028548055, 028548056, 028548062, 035191684, 035191685, 036319426, 037418951, 037420840, 038548054, 046329103, 046331161, 046331162, 047425769, 047426888, 047430967, 055225778, 056347830, 057432058, 057433632, 057436194, 058595423, 058595425, 067438321, 067442366, 067442479, 067446424, 067446425, 067448558, 068595426, 069876965, 069876966, 075255287, 076358119, 076361456, 077455530, 078595428, 078595430, 079891165, 079894758, 085258370, 085262947, 086369386, 086370993, 087459995, 087461380, 087465276, 087466267, 087469137, 088672403, 088672404, 088672405, 096372364, 096373205, 097471746, 098686643, 098686644, 098686645, 099937598, 104112739, 105265818, 106385210, 107481153, 107481154, 107483301, 108719992, 0111291154, 0111291943, 0111292218, 114132907, 114135079, 115290206, 117487787, 118740270, 118744198, 119983784, 119988027, 124153495, 125300048, 125301490, 127496634, 127513342,128738627, 128738628, 129996174, 0201048253, 0201048259, 0201066505, 0201066506, 0201066507, 0211311544, 0301076812, 0301076813, 0311324016, 0311324902, 0311325583, 0311329529, 0311329869, 0401098044, 0401098045, 0401098046, 0401100068, 0401100070, 0411345824, 0411346103, 0501101148, 0501101149, 0501128119, 0601150009, 0601150023, 0611366261, 0611367086, 0611368341, 0611369146, 0611369556, 0701168229, 0701169286, 0701169429, 0711373300, 0711381248, 0711389338, 0711390597, 0801188995, 0801189073, 0801192524, 0801192531, 0901192184, 0901202930, 0901203568, 0901204467, 0901204468, 1101243675, 1101245070, 1101246507, 1101247334, 1101256475, 1101256476, 1101257705, 1101258235, 1101261502, 1101261503, 1201261504, 1201262087, 1201262088, 1201265237, 1201265238, 1291001896 REF 26000019 Serial Numbers: 1401796, 1406150, 1408131, 1408232, 1419783, 1421313, 1421314, 1426641, 1430445, 1431154, 1432726, 1435036, 1435037, 1444788, 1446871, 1453902, 1466324, 1468716, 1472711, 1472712, 1472713, 1480599, 1480600, 1482073, 1483473, 1485542, 1488486, 1488487, 1490426, 1490540, 1494624, 1495078, 1496367, 1496368, 1497252, 1497253, 1503729, 1504265, 1511230, 1511233, 1511235, 1511958, 1511959, 1519173, 1519174, 1523541, 1526396, 1526397, 1526398, 1527826, 1532940, 1532941, 1534589, 1534590, 1542314, 1542315, 1543356, 1546506, 1548098, 1548099, 1553116, 1553117, 1553118, 1555113, 1555114, 1555115, 1561770, 1561771, 1567224, 1567225, 1567226, 1584584, 1584873, 1585000, 1593586, 1596667, 1601734, 1601735, 1601737, 1610139, 1612605, 1615704, 1618965, 1620426, 1622631, 1634730, 1634731, 1640316, 1640317, 1645758, 1645759, 1648022, 1648023, 1652752, 1652753, 1658819, 1658820, 02469870, 04474752, 05483518, 06346612, 06487166, 07348869, 07489911, 10352346, 10352748, 12358931, 015162545, 016305344, 016305905, 016306452, 017395721, 018521821, 018527649, 018528632, 019733515, 025191676, 025191677, 027406271, 036322012, 037415070, 037416897, 038548057, 038548058, 038548059, 047426244, 047426889, 055208759, 057432059, 057434554, 057438322, 058595432, 058595434, 066355137, 067442242, 067446427, 067448563, 075258158, 076358027, 076358747, 076360757, 077455531, 085255288, 086370992, 087461379, 087462400, 088595435, 088685248, 088685249, 096372365, 096374877, 097469510, 097479892, 0101001897, 0101018642, 104109640, 105269552, 105269553, 106373206, 106385212, 107481155, 107483329, 108685247, 108694954, 108703738, 0111283426, 114136099, 114136100, 117489010, 118739174, 118741129, 125300049, 125301516, 127496635, 127513345, 127513346, 127513347, 0201054130, 0201054131, 0201071228, 0201071229, 0211307793, 0211308184, 0301094599, 0301094600, 0301094601, 0301095303, 0301095306, 0311328007, 0311328322, 0401095307, 0411339436, 0411339437, 0411339438, 0511353339, 0511353340, 0601145547, 0601146379, 0601165146, 0601165561, 0611362537, 0611363313, 0611366309, 0611373793, 0711373882, 0711381474, 0711391927, 0711391991 0901196482, 0901196518, 0901196837, 0901197584, 1101236529, 1101237624, 1101238265, 1101239339, 1101255753, 1101255754, 1101256472, 1101256474, 1201269759, 1201269760, 1201275683 REF 26000020 Serial Numbers: 1405523, 1470079, 1502988, 1502989, 1523542, 1533183, 1544281, 1546507, 1553538, 1553539, 1561772, 1561773, 1587637, 1602314, 1615927, 1636055, 1638716, 1640919, 1648024, 1650421, 02469871, 06479693, 07346614, 08337217, 08351329, 11356228, 015162547, 018513348, 026319273, 035198677, 036321904, 037417014, 038548060, 047426243, 047427017, 055208760, 055208761, 056319428, 057432754, 058575583, 066356913, 067442243, 067448143, 068595437, 076360756, 076363042, 087455532, 087462040, 096373203, 097480710, 098694955, 107483330, 0111278279, 117487788, 127504546, 127507024, 128739175, 0211304893, 0211310148, 0301095294, 0511357836, 0711375057 REF 26000021 Serial Numbers: 01210330, 01210331, 01334608, 1389311, 1390744, 1392036, 1392704, 1399207, 1400720, 1404002, 1407102, 1407210, 1407488, 1409744, 1409954, 1415668, 1415669, 1416661, 1416662, 1426063, 1427396, 1431306, 1432314, 1434065, 1434066, 1435285, 1436957, 1438657, 1444329, 1444618, 1446165, 1455905, 1457130, 01460236, 1460645, 1460646, 1462754, 1468905, 1468906, 1470080, 1471505, 1473656, 1475743, 1476102, 1480460, 1482074, 1484469, 1484470, 1484769, 1484770, 1491260, 1491261, 1493552, 1496461, 1500102, 1500103, 1501282, 1503280, 1503730, 1507777, 1507778, 1511960, 1511961, 1511962, 1513943, 1513944, 1516242, 1516243, 1516969, 1516970, 1528275, 1528276, 1534592, 1534593, 1543353, 1543354, 1544279, 1544280, 1546508, 1555116, 1555117, 1555118, 1565734, 1565735, 1565736, 1568429, 1568430, 1581558, 1581559, 1581864, 1581865, 1590482, 1592574, 1594031, 1596668, 1597202, 1600813, 1600814, 1603004, 1610985, 1610986, 1611451, 1615929, 1619776, 1619777, 1634973, 1634974, 1640318, 1655444, 1655445, 1656992, 02465514, 02469872, 03210332, 03217507, 03217508, 04335947, 04339966, 04479694, 05483519, 06346617, 07489913, 08489912, 09228845, 09229554, 09351564, 09351689, 10356229, 11232604, 11355135, 12357450, 12359154, 12359799, 015162546, 016305126, 016314361, 018521822, 026316751, 026317142, 027394617, 027410097, 028521823, 028527650, 028528633, 028542658, 035191678, 035191679, 037415576, 037419471, 037419472, 038564682, 039824493, 039834733, 039837391, 039839758, 047424279, 047427018, 047431541, 049840545, 049843257, 049843791, 049843792, 049844822, 056343508, 057435218, 058595438, 058595439, 066347956, 067440502, 067442480, 067446428, 067448144, 068595440, 068595441, 069876612, 075250526, 076364822, 077459486, 078625404, 079890262, 079894024, 085267368, 087455533, 087466785, 087470688, 087471745, 088625406, 088672409, 088672411, 088685245, 096373201, 097480717, 098672410, 098685244, 098685246, 105258371, 106380199, 107483331, 109945428, 109960618, 0111277103 0111288491, 0111289477, 116385214, 117495022, 117495713, 118736946, 118740273, 119978890, 124140851, 125300062, 125304289, 126392066, 126394627, 127504547, 127507025, 0201035715, 0201044676, 0201050774, 0201059744, 0301072896, 0301072897, 0301081076, 0301081077, 0301085935, 0311310059, 0311310060, 0311315004, 0411339095, 0411339096, 0411339097, 0411339098, 0501115949, 0501116919, 0501118998, 0501119678, 0511354516, 0511354517, 0511357202, 0601142471, 0601148205, 0601151515, 0611362538, 0611365401, 0611366310, 0611374826, 0701162968, 0701163563, 0701171826, 0711388906, 0801188058, 0901197221, 0901206707, 0901206708, 1001218546, 1001228991, 1101243617, 1101251429, 1101256240, 1101256241, 1101256242, 1101256243, 1101260335, 1201267601, 1201267602, 1201273043, 1291000330, 1291017281, 1291017718, 1291017719, 16008131604573 REF 26000022 Serial Numbers: 01210333, 01210744, 01210745, 01334612, 1392476, 1392705, 1396837, 1396841, 1399341, 1400518, 1402203, 1404278, 1404489, 1407215, 1407487, 1409305, 1409515, 1414006, 1414824, 1414825, 1416411, 1419552, 1419849, 1421315, 1421316, 1425082, 1426584, 1426585, 1428862, 1428863, 1431009, 1431152, 1431153, 1433645, 1433646, 1435286, 1435680, 1436958, 1437263, 1437264, 1440450, 1441515, 1444036, 1444195, 1444785, 1444786, 1444975, 1447129, 1448611, 1456416, 1457554, 1460129, 1460130, 1462756, 1464086, 1468466, 1468718, 1470779, 1471688, 1473070, 1476103, 1477378, 1483275, 1483276, 1485330, 1485331, 1485364, 1485365, 1485541, 1487539, 1493551, 1497572, 1498036, 1498037, 1501036, 1501037, 1501327, 1503281, 1503731, 1506325, 1506326, 1507935, 1507936, 1510461, 1510462, 1510463, 1513945, 1513946, 1513947, 1515635, 1515636, 1515694, 1515695, 1519177, 1523543, 1528502, 1528503, 1532401, 1532402, 1536699, 1536700, 1536701, 1541033, 1541034, 1541035, 1544285, 1544286, 1544287, 1546973, 1546974, 1554790, 1554791, 1554792, 1556779, 1556780, 1556781, 1556782, 1561463, 1561464, 1561465, 1561466, 1567227, 1567228, 1567229, 1569901, 1569902, 1569903, 1569904, 1582251, 1582252, 1590077, 1590461, 1590462, 1591051, 1592576, 1593587, 1594032, 1594881 1597203, 1599335, 1600811, 1600812, 1601731, 1601732, 1606609, 1606610, 1607592, 1608836, 1610561, 1610562, 1611452, 1615572, 1615705, 1616178, 1620678, 1620679, 1620680, 1634975, 1634976, 1637238, 1648025, 1648026, 1648619, 1648620, 1655446, 1655447, 1658514, 1658515, 02460237, 02461648, 02468619, 02469873, 03211705, 03211906, 03211910, 03217509, 03217510, 03335948, 03339965, 03474753, 04217269, 04479695, 05483520, 06219768, 06219769, 06341527, 06345236, 06346616, 06489179, 07489914, 08348870, 08349026, 09229551, 09351690, 10351707, 10356230, 11232605, 12355136, 12357110, 015162435, 015162436, 016294652, 016303114, 016306455, 018521824, 018521825, 018523883, 018523884, 027412434, 035191680, 035191681, 035198491, 036322010, 037414680, 037416655, 037419752, 037420843, 038544856, 038544857, 038548061, 039819344, 039821131, 039825300, 039836605, 039837392, 046319425, 047426891, 047429086, 049832652, 049838305, 049840544, 049843310, 056331164, 056343507, 057435219, 058595442, 058595443, 065244421, 066347949, 067440182, 067442481, 067442482, 067446429, 068595444, 068595445, 068595446, 069872992, 069872993, 069876967, 069876968, 075245202, 076360910, 076363530, 076365178, 076365891, 077450128, 077455534, 078625407, 078625408, 079894023, 079894759, 085258372, 086369487, 087461047, 087462399, 087466268, 087469126, 087470003, 088672400, 088672401, 088672402, 089904047, 094104770, 096371131, 096373883, 096374876, 097480718, 098686646, 098686647, 098686648, 098694956, 099929426, 099937599, 0101000331, 0101016260, 0101029687, 105265819, 105275571, 105286916, 107483332, 108706225, 108706226, 108713332, 109944907, 109955347, 109958793, 0111277102, 114112742, 116385211, 117487789, 117496636, 118738629, 118738644, 118739655, 118744193, 119976423, 119976424, 124145838, 125307855, 126392067, 126395276, 126395722, 127504548, 127505594, 127507026, 129983786, 129998778, 0201029688, 0201053792, 0201053814, 0201062914, 0201062915, 0201062916, 0201062917, 0211300500, 0211301131, 0211302254, 0301078356, 0301080502, 0301089723, 0301089724, 0301089725, 0301089726, 0311318061, 0311318866, 0311321116, 0311322523, 0401106430, 0401108732, 0401109393, 0401109394, 0401112109, 0411333202, 0411339439, 0411339440, 0411339441, 0411339442, 0411339443, 0411346844, 0411346845, 0501115011, 0501115559, 0501124773, 0501124864, 0501131797, 0501132629, 0501142048, 0501142198, 0511346962, 0511353341, 0601147116, 0601147180, 0601160630, 0611353342, 0611359114, 0611371891, 0611371941, 0701161822, 0701172647, 0701173465, 0701173482, 0701180405, 0701181072, 0711372612, 0711380277, 0711389319, 0711389337, 0711390551, 0711390596, 0801188152, 0801188638, 0901195838, 0901205530, 0901205532, 0901206125, 1101247390, 1101248665, 1101249266, 1101249421, 1101250724, 1101252573, 1101253677, 1101253729, 1201270046, 1201270047, 1201270048, 1201270049, 1201271744, 1201271756 REF 26000023 Serial Numbers: 01210328, 01210329, 01210334, 01334607, 1391134, 1391967, 1392022, 1399342, 1399523, 1410249, 1410250, 1414894, 1414895, 1419850, 1420737, 1425873, 1427398, 1431010, 1431453, 1435893, 1435894, 1437326, 1444448, 1444787, 1445941, 1448012, 1469526, 1470780, 1472881, 1473067, 1476607, 1479549, 1479550, 1480095, 1482752, 1484771, 1485538, 1489820, 1490428, 1491266, 1491268, 1496462, 1498038, 1498039, 1501283, 1501284, 1503282, 1503732, 1509295, 1509296, 1513948, 1513949, 1513950, 1516244, 1516245, 1523544, 1528086, 1528087, 1540934, 1540935, 1540936, 1543357, 1543358, 1548273, 1555119, 1555120, 1555121, 1557969, 1557970, 1566398, 1566399, 1566400, 1568427, 1568428, 1570710, 1570711, 1570712, 1590484, 1592575, 1594033, 1600184, 1600810, 1607802, 1607803, 1611262, 1611450, 1615573, 1622632, 1622633, 1640627, 1648367, 1648626, 1656993, 1656994, 02210336, 02461298, 02461649, 03210335, 04335950, 04339969, 04479696, 05483521, 06219765, 06219766, 07490491, 07492049, 08351706, 09226599, 09353291, 09353668, 10356231, 11226598, 11358852, 12235138, 12355137, 12359801, 015158578, 015165779, 016306454, 016314362, 017398847, 017403583, 018521826, 018523885, 025170081, 025191038, 025191196, 027406272, 027410274, 036319427, 036322013, 037418952, 037420844, 038544858, 039821130, 039824494, 039832653, 045198492, 047426892, 048575584, 048585743, 049838306, 049841551, 057432755, 057436426, 058594216, 058595447, 058595448, 065245201, 066355138, 067442483, 067446430, 067450512, 068595466, 069879081, 075249042, 076358028, 076360758, 076363043, 077455535, 078625409, 078625410, 079890265, 079890267, 079890269, 079891166, 079894760, 084100343, 085258373, 086364823, 087459184, 087462044, 088679474, 089927667, 096373885, 097479891, 097480719, 098693693, 099931101, 099931102, 0101022067, 0101022068, 104109600, 105265820, 105277296, 107483333, 108693692, 108694957, 109955348, 0111275709, 0111286672, 114132908, 116389340, 117495023, 118706227, 118743308, 119976425, 119976426, 124153494, 125300061, 125303468, 125306189, 126391601, 127504549, 127505595, 127507027, 128739654, 129998780, 129998781, 0201053794, 0201053815, 0201071230, 0201071231, 0301080504, 0301089727, 0311314247, 0311316420, 0311329145, 0311329525, 0311329868, 0311330086, 0311330556, 0311332183, 0401105191, 0401105658, 0401110401, 0401111498, 0401111632, 0411339444, 0411339445, 0501120033, 0501125521, 0501137716, 0501138318, 0501138642, 0601138735, 0601164238, 0601165033, 0611370671, 0711370344, 0711370672, 0711379604, 0711380154, 0801182759, 0801182761, 0801193309, 0801193417, 0801194319, 1101240494, 1101240495, 1101240526, 1101241565, 1101242470, 1101243259, 1101243260, 1201267537, 1201267538, 1291016261 REF 26000024 Serial Numbers: 01210341, 01334609, 1406711, 1435113, 1449965, 1473068, 1501285, 1504260, 1506157, 1506158, 1516246, 1523545, 1532942, 1540932, 1540933, 1546509, 1546972, 1564765, 1564766, 1567230, 1567231, 01583522, 1600185, 1608033, 1611453, 1634732, 1635410, 1639319, 1639320, 1645174, 1648368, 1648627, 03474754, 04335949, 04335951, 04479697, 05485501, 06219767, 08346615, 09226600, 09229553, 09497828, 10356232, 12359155, 12359802, 016305926, 01630645, 018521827, 018521828, 018523886, 025179480, 026318355, 037416746, 047426893, 047431540, 048585738, 055225777, 056343509, 057432756, 057436489, 066347957, 067445022, 075245203, 077450627, 078595467, 085258374, 086364821, 087455536, 087469055, 095264009, 096374875, 105277299, 107486693, 108660967, 109947893, 109964117, 118733325, 124136101, 124158576, 126389857, 126395277, 127512693, 128733324, 128738339, 129998782, 0201044379, 0211308909, 0301078357, 0301100065, 0301100067, 0311316582, 0401106035, 0501127371, 0611373287, 0711373247, 0901194832, 0901194834, 1201266194, 1201274863, 1291016262 REF 26000025 Serial Numbers: 1395467, 1396575, 1397861, 1398723, 1398896, 1399773, 1399814, 1400721, 1402023, 1404222, 1404490, 1405724, 1405892, 1410826, 1410992, 1416412, 1417307, 1417308, 1417777, 1417778, 1426064, 1426586, 1427399, 1429434, 1430350, 1430351, 1432723, 1432724, 1432725, 1434063, 1434260, 1434261, 1441514, 1447130, 1452147, 1452148, 1456731, 1459787, 1459807, 01460238, 1461406, 1461407, 1463852, 1464781, 1464782, 1468041, 1470963, 1471176, 1472042, 1473069, 1475024, 1476982, 1479895, 1479896, 1480428, 1480461, 1483471, 1484772, 1484773, 1490430, 1490539, 1497527, 1497528, 1497573, 1497574, 1497575, 1502049, 1505250, 1505251, 1505592, 1505876, 1505877, 1506699, 1506700, 1509303, 1509305, 1513951, 1513952, 1513953, 1520540, 1520541, 1520542, 1521200, 1521201, 1521731, 1522475, 1523886, 1525248, 1528616, 1528617, 1528618, 1529767, 1530737, 1530738, 1531372, 1531559, 1533184, 1533185, 1539540, 1539541, 1539542, 1539543, 1543355, 1544022, 1544288, 1544289, 1546216, 1548100, 1548101, 1548793, 1548794, 1550353, 1550354, 1553544, 1553545, 1553546, 1554785, 1554786, 1556783, 1556784, 1556785, 1556786, 1560840, 1560841, 1565737, 1565738, 1565739, 1565740, 1570920, 1570921, 1570922, 1576847, 1576848, 1576849, 1576850, 1582750, 1582751, 1582752, 1583512, 1589538, 1589725, 1590828, 1591512, 1592284, 1592377, 1592577, 1598152, 1598153, 1603957, 1603958, 1605902, 1605903, 1608031, 1608837, 1610134, 1613897, 1613898, 1613899, 1613900, 1615401, 1617609, 1617610, 1621175, 1621176, 1633866, 1633867, 1637239, 1637240, 1637400, 1637401, 1640920, 1641177, 1641266, 1643942, 1643943, 1645360, 1645361, 1649376, 1649377, 1649378, 1653527, 1653941, 1655093, 1655094, 1655095, 1660417, 1660418, 1660419, 02461297, 03210340, 04210347, 04474755, 04479698, 06485502, 08348872, 09494170, 12356233, 016311730, 016311731, 017398862, 017404755, 018523887, 025179482, 037420327, 038564678, 038566589, 038567197, 039809783, 039828327, 039831048, 047426894, 048585740, 049839757, 049842582, 055211009, 057432757, 057438323, 058595338, 058605218, 065227870, 067442484, 068625412, 069870369, 075250528, 077455256, 078651460, 078660968, 079890271, 079891167, 087465273, 087469506, 087471663, 088679475, 089905087, 089912891, 089915882, 089924905, 089926242, 089929627, 097473752, 099937600, 0101013692, 0101020921, 0101020922, 101046898, 0101048291, 0101048292, 104109643, 105258375, 105275573, 107482923, 107486694, 108688676, 108694958, 108713333, 109944908, 0111293922, 0111295010, 114131981, 117506038, 117506039, 119970864, 119986953, 124135080, 124135081, 125294651, 125307997, 126396172, 127507028, 128743303, 129989231, 0201071232, 0201074285, 0211296735, 0211297626, 0301071233, 0301074284, 0311324901, 0311325545, 0311325581, 0401099033, 0401101150, 0401104097, 0401112925, 0401121017, 0401121190, 0401121935, 0411334830, 0411334831, 0411335373, 0411335374, 0411335375, 0411335376, 0501128425, 0501128927, 0501136396, 0501137369, 0601147954, 0601154260, 0601154738, 0601158914, 0601159616, 0611369557, 0611370352, 0611371971, 0611371972, 0611372616, 0701171293, 0701171921, 0701171982, 0701181919, 0701182353, 0711388280, 0711388281, 0711389894, 0711389895, 0901192133, 0901200718, 0901200724, 0901201439, 0901212159, 1001212319, 1201260895, 1201260897, 1201260899, 1201262085, 1201262086, 1201265234, 1201265235, 1201275684, 1291013693 REF 26000026 Serial Numbers: 1395468, 1396342, 1396576, 1396577, 1398013, 1399012, 1399092, 1399343, 1399780, 1399781, 1400013, 1400722, 1402502, 1406151, 1407809, 1407837, 1407993, 1409086, 1411158, 1411233, 1413507, 1413958, 1416659, 1416660, 1418715, 1420561, 1420562, 1421012, 1421014, 1424399, 1425874, 1425875, 1427400, 1427401, 1427724, 1429435, 1429436, 1431155, 1431156, 1434064, 1434106, 1434262, 1434263, 1434947, 1435284, 1436537, 1437780, 1438128, 1445942, 1448771, 1452342, 1453180, 1453903, 1456733, 1457555, 1458651, 1459358, 1459550, 1462757, 1463679, 1466554, 1468039, 1468040, 1469680, 1470781, 1471177, 1471506, 1472043, 1473328, 1474204, 1475084, 1476462, 1476777, 1476778, 1479030, 1479031, 1479551, 1479552, 1483274, 1483468, 1483469, 1483470, 1490527, 1490530, 1497491, 1497576, 1497577, 1497579, 1497580, 1497582, 1501328, 1502050, 1502051, 1502052, 1505252, 1505253, 1505254, 1505255, 1505593, 1505594, 1505878, 1506697, 1506698, 1507570, 1507571, 1508081, 1508082, 1509239, 1509240, 1509307, 1509308, 1510887, 1511963, 1511964, 1511965, 1520543, 1520544, 1520545, 1521418, 1521419, 1521420, 1521421, 1521732, 1522474, 1523631, 1523632, 1523633, 1523885, 1525249, 1525250, 1529221, 1529222, 1529223, 1529224, 1530739, 1530740, 1530741, 1531560, 1531561, 1533186, 1533187, 1533188, 1534594, 1534595, 1539544, 1539545, 1539546, 1539547, 1540823, 1540824, 1540825, 1543359, 1543360, 1543361, 1544290, 1544291, 1546217, 1547297, 1548102, 1548103, 1548795, 1548796, 1550351, 1550352, 1551552, 1552126, 1552127, 1554782, 1554783, 1554784, 1556787, 1556788, 1556789, 1556790, 1560838, 1560839, 1560940, 1560941, 1560942, 1566401, 1566402, 1566786, 1566787, 1566788, 1566789, 1570923, 1570924, 1572013, 1572014, 1572015, 1577848, 1577849, 1577850, 1577851, 1578039, 1578040, 1578328, 1578329, 1588738, 1588739, 1588740, 1588741, 1589114, 1589126, 1589127, 1593366, 1597204, 1598154, 1598155, 1599336, 1603005, 1603006, 1603007, 1603697, 1603959, 1605900, 1605901, 1607569, 1607570, 1608032, 1608838, 1609813, 1609814, 1614087, 1614088, 1614089, 1614985, 1614986, 1614987, 1614988, 1615400, 1615926, 1618513, 1618514, 1618515, 1618516, 1619775, 1621177, 1621178, 1622634, 1623480, 1623481, 1633691, 1633692, 1637402, 1637403, 1641265, 1643612, 1643613, 1643614, 1644908, 1644909, 1646058, 1646400, 1649158, 1649159, 1649160, 1650957, 1650958, 1652571, 1653580, 1653940, 1654505, 1654506, 1654507, 1655091, 1655092, 1657876, 1661716, 1661717, 02461650, 03211706, 03474756, 04338849, 04342275, 04479699, 08346613, 08489180, 08494179, 09227484, 09497825, 09499461, 10356234, 12357091, 015158579, 015170083, 016303113, 016307998, 018521829, 018521830, 027408822, 027410505, 028527651, 029809784, 038564680, 039821129, 039828329, 039828331, 039833520, 047424093, 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0201059394, 0201074286, 0211306009, 0211306393, 0211307060, 0301074287, 0301084473, 0301084475, 0311319152, 0311320056, 0311320057, 0311322522, 0311324014, 0311331668, 0401099034, 0401101151, 0401101152, 0401104098, 0401112937, 0401122034, 0411331739, 0411332563, 0411333201, 0411334772, 0411344343, 0411344344, 0411345497, 0501116687, 0501123240, 0501123311, 0501127070, 0501127370, 0501133074, 0501134099, 0501134957, 0501143656, 0501143754, 0601145033, 0601157869, 0611358067, 0611358252, 0611359163, 0611376329, 0611378284, 0611378752, 0611378940, 0701157306, 0701170750, 0701170801, 0701177942, 0701178446, 0701178474, 0711388282, 0711388907, 0711389148, 0711390647, 0711392706, 0801189095, 0801189691, 0801189731, 0801197634, 0801198120, 0901198291, 0901199318, 0901201662, 0901202102, 0901202875, 0901213558, 0901213853, 0901214167, 1001214166, 1101243676, 1101245036, 1101246508, 1101247356, 1101248453, 1101248667, 1101249422, 1101250726, 1101252574, 1101253678, 1101253730, 1291013696, 1291013697, 16436121646767 REF 26000027 Serial Numbers: 1395469, 1396578, 1397181, 1397182, 1399209, 1399524, 1400519, 1401808, 1404831, 1405271, 1408373, 1408406, 1411594, 1412034, 1415989, 1415990, 1417309, 1417310, 1417959, 1417961, 1422753, 1422754, 1427402, 1430352, 1430353, 1431454, 1435173, 1435283, 1435895, 1435896, 1438129, 1446145, 1449059, 1455939, 1455940, 1458005, 1458006, 1462443, 1462690, 1464087, 1466555, 1469681, 1469922, 1470782, 1471690, 1472268, 1476179, 1476180, 1476981, 1481230, 1481231, 1483277, 1484468, 1484776, 1490517, 1497493, 1497529, 1497581, 1498055, 1498784, 1498785, 1502053, 1505151, 1505152, 1505153, 1505177, 1505879, 1505880, 1507568, 1507569, 1508079, 1508080, 1511966, 1511967, 1511968, 1513954, 1513955, 1521202, 1521729, 1521730, 1522471, 1522472, 1523634, 1523635, 1523887, 1528949, 1528951, 1528953, 1528954, 1530742, 1530743, 1531373, 1531562, 1533189, 1533190, 1534596, 1536702, 1536704, 1540820, 1540821, 1540822, 1543362, 1543985, 1543986, 1546218, 1546219, 1548274, 1548275, 1552128, 1552129, 1554779, 1554780, 1554781, 1560032, 1560033, 1560034, 1560035, 1561774, 1561775, 1561776, 1565992, 1567763, 1567764, 1572471, 1572472, 1572473, 1576047, 1576048, 1576049, 1576050, 1587914, 1587915, 1587917, 1590829, 1592378, 1593368, 1597205, 1598156, 1598157, 1600182, 1600183, 1603961, 1603962, 1604754, 1605893, 1607588, 1607590, 1609169, 1610136, 1614758, 1614759, 1618962, 1618963, 1618964, 1621629, 1623482, 1623483, 1623484, 1634154, 1634155, 1639541, 1640921, 1640922, 1643615, 1643616, 1644911, 1646059, 1649611, 1649612, 1649613, 1654237, 1654238, 1654239, 1657877, 02461294, 02461651, 03210338, 03210348, 04479700, 06342276, 07489181, 08348868, 09494180, 09497826, 10352347, 12360241, 017399379, 017404756, 027407673, 028523888, 028527652, 035179481, 035198676, 038552347, 039809786, 039830315, 039832650, 039832651, 046330150, 047426441, 048585764, 049841552, 056340859, 057434553, 057438325, 058594218, 058595471, 066355139, 067442486, 068595470, 068605221, 069870370, 075250530, 076358512, 077455261, 078605222, 079890273, 079890275, 085258377, 087465275, 087467824, 087469508, 087470853, 088683522, 088683523, 089901148, 089912892, 089915884, 089922649, 097473754, 097478811, 099937602, 0101013698, 0101013699, 0101029693, 0101029696, 105269554, 105269555, 106366811, 107482925, 107486696, 107486697, 108713334, 108713694, 109949207, 114135083, 118733326, 119973178, 119986956, 124140852, 126390045, 127500341, 127504551, 127507030, 128737887, 128742804, 129990538, 0201053796, 0201053797, 0201066508, 0201071234, 0201071235, 0301081713, 0311314214, 0311317715, 0311325658, 0311329527, 0401096839, 0401104099, 0401114367, 0401114509, 0411329867, 0411330087, 0411330599, 0411344036, 0411344037, 0501126458, 0501126876, 0501136266, 0501139842, 0601148122, 0601155524, 0601156525, 0611368954, 0611368955, 0701169799, 0701170011, 0701170120, 0711374908, 0711387924, 0711387925, 0711388283, 0711390745, 0711392707, 0801190503, 0801191385, 0901190508, 0901191344, 0901209976, 0901210580, 0901211643, 1101258587, 1101259118, 1101259122, 1101261500, 1201261499, 1201261501, 1201262080, 1201262082, 1201262083, 1201265229, 1201265232 REF 26000028 Serial Numbers: 1391135, 1400287, 1406168, 1412299, 1415479, 1417633, 1420013, 1435172, 1438656, 01457092, 1457966, 1462758, 1470964, 1472301, 1473329, 1485537, 1489846, 1498786, 1502054, 1505154, 1505595, 1507566, 1507567, 1510370, 1510464, 1511227, 1511228, 1522473, 1524014, 1531563, 1534597, 1539548, 1539549, 1543363, 1543364, 1546220, 1548276, 1548277, 1553774, 1553775, 1560036, 1560037, 1561777, 1561778, 1561779, 1572474, 1572475, 1572476, 1588490, 1588491, 1593367, 1600180, 1600181, 1605894, 1606608, 1609170, 1614090, 1615399, 1616177, 1617417, 1618062, 1621875, 1623485, 1633439, 1633440, 1636636, 1636637, 1641264, 1643611, 1644910, 1645359, 1646060, 1646061, 1648946, 1648947, 1650955, 1650956, 1653939, 1654235, 1654236, 1657878, 1661713, 1661714, 04339973, 04479701, 06210349, 06345233, 07487219, 08348871, 09489182, 09494181, 12356235, 015170084, 01630
Other Recalls from MicroPort Orthopedics Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1133-2026 | Class II | Brand Name: MicroPort Product Name: HIPTURN FE... | Dec 19, 2025 |
| Z-0699-2025 | Class II | EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZ... | Oct 29, 2024 |
| Z-2244-2024 | Class II | EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-p... | May 3, 2024 |
| Z-0275-2023 | Class II | EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ET... | Oct 28, 2022 |
| Z-0276-2023 | Class II | EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETP... | Oct 28, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.