# FDA recall Z-1458-2020

> **Nextremity Solutions** · Class II · device recall initiated 2020-02-12.

## 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

## Distribution

International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.

## Key facts

- **Recall number:** Z-1458-2020
- **Recalling firm:** Nextremity Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-12
- **Report date:** 2020-03-18
- **Termination date:** 2020-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2020

## Citation

> AI Analytics. FDA recall Z-1458-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1458-2020. Source: US FDA. Licensed CC0.

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