Nextra Hammertoe Correction System-4 — Class II medical device recall Z-1458-2020
Terminated recall by Nextremity Solutions, reported 2020-03-18. Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it
| Recall number | Z-1458-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nextremity Solutions, Warsaw, IN, United States |
| Recall initiated | 2020-02-12 |
| Classified | 2020-03-09 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2020-12-17 |
| Countries outside the US | CH, DE, ES, GB |
| Quantity | 190 units |
| UPC / GTIN / UDI-DI | 00817701020011 |
| Lot numbers | 168117318B |
| Model numbers | NX-4532K |
Product
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Reason for recall
Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
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-1458-2020. 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.