Lineage Shell: REF 36693646 — Class III medical device recall Z-0686-2017
Terminated recall by MicroPort Orthopedics Inc., reported 2016-12-07, distributed nationwide. Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal
| Recall number | Z-0686-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MicroPort Orthopedics Inc., Arlington, TN, United States |
| Recall initiated | 2016-06-21 |
| Classified | 2016-12-01 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CN, CY, CZ, DE, DK, ES, FI, FR, GB, GR, IR, IT, JM, JP, KR, LT, MY, NL, PH, PL, PT, RU, SI, TR, TW, VN, ZA |
| Quantity | 22 units |
| Serial numbers | 08228745, 08228747, 09229086, 09229091, 09229131, 09229167, 09229169, 09229170, 09230501, 09230503, 09230505, 09230506, 09230507, 09230967, 10230508, 10230509, 10230510, 10230511, 10230512, 11230847, 11235075, LLALMB161A |
| Model numbers | 36693646, 36693848, 36694050, 36694252, 36694454, 36694656, 36694858, 36695060, 36695262, 36695464 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0686-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.