Equinoxe Cage — Class II medical device recall Z-0415-2018
Terminated recall by Exactech, Inc., reported 2018-02-07, distributed in AL, AZ, CA, CO, FL, GA, ME, MN…. Potentially mislabeled.
| Recall number | Z-0415-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2017-08-31 |
| Classified | 2018-01-26 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-08-06 |
| Distributed | AL, AZ, CA, CO, FL, GA, ME, MN, OH, OK, PR, SC, TN, VA, WI |
| Countries outside the US | CH |
| Quantity | 30 |
| Reason classes | labeling |
| Model numbers | 314-13-03 |
Product
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Reason for recall
Potentially mislabeled.
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-0415-2018. 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.