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
Check against the official notice below — it lists the full affected range.
MicroPort Orthopedics Inc. is recalling 108,362 units of Transcend and Conserve cobalt chromium modular hip replacement heads distributed worldwide, including throughout the United States. The recall addresses an increasing trend in revision rates for metal-on-metal total hip arthroplasty systems from 2009 to the present, with a specific concern that more than one percent of Conserve modular head systems combined with Dynasty metal acetabular liner systems showed suspected tissue reactions to metal debris.
The record does not specify any remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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 Kin Quantity: 108,362 units Lot/code info: 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,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.