Equinoxe Platform Fracture Stem — Class II medical device recall Z-0307-2021
Terminated recall by Exactech, Inc., reported 2020-11-04, distributed nationwide. The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left st
| Recall number | Z-0307-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2020-09-25 |
| Classified | 2020-10-29 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, DE, ES, FR, GB, IN, IT, KR, LU, SG |
| Quantity | 25 devices |
| Model numbers | 304-21-07 |
Product
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Reason for recall
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
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-0307-2021. 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.