Vilex — Class II medical device recall Z-1721-2015
Terminated recall by Vilex In Tennessee Inc, reported 2015-06-17, distributed in MD, MS, PA, TX. Incidence of breakage is higher than expected.
| Recall number | Z-1721-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vilex In Tennessee Inc, Mcminnville, TN, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-06-08 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-10-30 |
| Distributed | MD, MS, PA, TX |
| Quantity | 13 units |
| Reason classes | device malfunction |
Product
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Reason for recall
Incidence of breakage is higher than expected.
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-1721-2015. 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.