# FDA recall Z-1857-2025

> **Onkos Surgical, Inc.** · Class II · device recall initiated 2024-09-22.

## Product

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E.    Component of ELEOS Limb Salvage System

## Reason for recall

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

## Distribution

US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

## Key facts

- **Recall number:** Z-1857-2025
- **Recalling firm:** Onkos Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-22
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1857-2025

## Citation

> AI Analytics. FDA recall Z-1857-2025. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-1857-2025. Source: US FDA. Licensed CC0.

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