Nextra Hammertoe Correction System 4 — Class II medical device recall Z-0911-2022
Terminated recall by Nextremity Solutions, reported 2022-04-20, distributed nationwide. Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remo
| Recall number | Z-0911-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nextremity Solutions, Warsaw, IN, United States |
| Recall initiated | 2022-02-10 |
| Classified | 2022-04-12 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2024-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL |
| Quantity | 459 units |
| UPC / GTIN / UDI-DI | 00817701020004 |
| Lot numbers | 168117318C, 168125017D |
Product
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
Reason for recall
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
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-0911-2022. 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.