# FDA recall Z-2425-2025

> **Onkos Surgical, Inc.** · Class II · device recall initiated 2025-07-11.

## Product

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

## Reason for recall

Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

## Distribution

US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.

## Key facts

- **Recall number:** Z-2425-2025
- **Recalling firm:** Onkos Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-11
- **Report date:** 2025-09-03

- **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-2425-2025

## Citation

> AI Analytics. FDA recall Z-2425-2025. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2425-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*