Conserve Cups: REF 38BF3642 — Class III medical device recall Z-0688-2017
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-0688-2017 |
|---|---|
| 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 | 68,221 units |
| Serial numbers | 016277854, 016283870, 016283871, 016283872, 016300068, 018495671, 019741984, 019745503, 019746760, 025128517, 025128518, 025128519, 025128520, 025140464, 025142838, 025144180, 025144201, 025146436, 025146459, 025146460, 025149111, 025149144, 025149290, 025149838, 025150758 and 394 more |
| Model numbers | 38BF3642, 38BF3642SP, 38BF3844, 38BF3844SP, 38BF4046, 38BF4046SP, 38BF4248, 38BF4248SP, 38BF4450, 38BF4450SP, 38BF4652, 38BF4652SP, 38BF4854, 38BF5056, 38BF5258, 38BF5258SP, 38BF5460, 38BF5460SP, 38BF5662, 38BF5662SP, 38BF5864, 38BF5864SP, 38BF6066, 38BF6066SP, 38QH3644 and 23 more |
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 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-0688-2017. 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.