# FDA recall Z-1882-2025

> **Onkos Surgical, Inc.** · Class II · device recall initiated 2023-09-01.

## Product

Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M.    Component of ELEOS LIMB SALVAGE SYSTEM

## Reason for recall

Potential for breach of Tyvek seals.

## Distribution

Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.

## Key facts

- **Recall number:** Z-1882-2025
- **Recalling firm:** Onkos Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-01
- **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-1882-2025

## Citation

> AI Analytics. FDA recall Z-1882-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1882-2025. Source: US FDA. Licensed CC0.

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