# FDA recall Z-1818-2025

> **Onkos Surgical, Inc.** · Class II · device recall initiated 2023-12-22.

## Product

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM.  Model Number: HC-15120-03M.    Component of Limb Salvage System with BioGrip.

## Reason for recall

Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package.  The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

## Distribution

US Nationwide distribution in the states of California, Kentucky, and Wisconsin.

## Key facts

- **Recall number:** Z-1818-2025
- **Recalling firm:** Onkos Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-22
- **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-1818-2025

## Citation

> AI Analytics. FDA recall Z-1818-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1818-2025. Source: US FDA. Licensed CC0.

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