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FDAFDA · Alimentos y medicamentos·N.º oficial 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

Publicado el 7 de diciembre de 2016 · Inicio del retiro: 21 de junio de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
MicroPort Orthopedics Inc.
Distribuidor
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.
Lote
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
Clasificación de riesgo
Class III
Área (FDA)
device
País
United States

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