FDA Device recall Z-0689-2017
Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 260000…
- FDA Device
- Class III
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class III recall of Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 260000… by Microport Orthopedics, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0689-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-21 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Microport Orthopedics |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Transcend REF 26000017 Serial Numbers: 1392035, 1394262, 1403269, 1404128, 1405348, 1406868, 1416193, 1416410, 41…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, 032175 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0689-2017%22
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