FDA Device recall Z-0688-2017
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF…
- FDA Device
- Class III
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class III recall of Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF… 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-0688-2017 |
| 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
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864, REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058, REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852, REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672 For use with the conserve metal head
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 | REF 38BF3642 Serial Numbers: 1380112, 1399025, 1402166, 1340677, 1427276, 1429743 REF 38BF3642SP Serial Number…REF 38BF3642 Serial Numbers: 1380112, 1399025, 1402166, 1340677, 1427276, 1429743 REF 38BF3642SP Serial Number 1416590 REF 38BF3844 Serial Numbers: 1368260, 1402167, 1399026, 1380113, 1418795 REF 38BF3844SP Serial Number 1416814 REF 38BF4046 Serial Numbers: 1368261, 1380114, 1402168, 1399027, 1418796, 1429744, 1449113 REF 38BF4046SP Serial Number 1416950 REF 38BF4248 Serial Numbers: 1397139, 1368262, 1381417, 1399029, 1422026, 1418797, 1433514, 1449114, 1452995 REF 38BF4248SP Serial Number 1416816 REF 38BF4450 Serial Numbers: 1380115, 1399031, 1399231, 1373711, 1366654, 1418948, 1433515, 1431187, 1449115, 1482461, 1484998 REF 38BF4450SP Serial number 1416563 REF 38BF4652 Serial Numbers: 1380116, 1395709, 1368263, 1373712, 1399233, 1427277, 1429745, 1433516, 1445264, 1449116, 1460186, 1460187, 1482463, 1481980 REF 38BF4652SP Serial Numbers: 1417403, 1417616 REF 38BF4854 Serial Numbers: 1381418, 1399234, 1373904, 1368264, 1399 |
|---|
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-0688-2017%22
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