FDA Device recall Z-0686-2017
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262…
- FDA Device
- Class III
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class III recall of Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262… 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-0686-2017 |
| 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
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 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 36693646 Serial Numbers: 09230967, 09229086, 10230508 REF 36693848 Serial Numbers: 08228745, 10230509, 11235…REF 36693646 Serial Numbers: 09230967, 09229086, 10230508 REF 36693848 Serial Numbers: 08228745, 10230509, 11235075 REF 36694050 Serial Numbers: 09229091, 09230501 REF 36694252 Serial Numbers: 09229131, 10230510 REF 36694454 Serial Numbers: LLALMB161A, 09230503 REF 36694656 Serial Numbers: 09230505, 11230847 REF 36694858 Serial Numbers: 09229167, 10230511 REF 36695060 Serial Numbers: 09229169, 09230506 REF 36695262 Serial Numbers: 09230507, 09229170 REF 36695464 Serial Numbers: 08228747, 10230512 |
|---|
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-0686-2017%22
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