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FDAFDA · Food and drugs·Recall number Z-0689-2017

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

Published December 7, 2016 · Recall initiated: June 21, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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 to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
MicroPort Orthopedics Inc.
Distributor
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
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, 16525
Risk classification
Class III
Area (FDA)
device
Country
United States

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