# FDA recall Z-2042-2025

> **Onkos Surgical, Inc.** · Class II · device recall initiated 2025-05-20.

## Product

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003.      It is a component of a Custom Constrained Shoulder Arthroplasty Device

## Reason for recall

Required inspections were not performed on finished product prior to release and distribution.

## Distribution

US Nationwide distribution in the state of Maryland.

## Key facts

- **Recall number:** Z-2042-2025
- **Recalling firm:** Onkos Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-20
- **Report date:** 2025-07-09

- **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-2042-2025

## Citation

> AI Analytics. FDA recall Z-2042-2025. Retrieved 2026-09-14 from https://api.ai-analytics.org/recall/Z-2042-2025. Source: US FDA. Licensed CC0.

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