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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