# FDA recall Z-1651-2025

> **Tornier, Inc** · Class II · device recall initiated 2025-03-03.

## Product

stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE,  Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

## Reason for recall

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking.  "	Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect)  "	Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

## Distribution

OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany

## Key facts

- **Recall number:** Z-1651-2025
- **Recalling firm:** Tornier, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2025

## Citation

> AI Analytics. FDA recall Z-1651-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1651-2025. Source: US FDA. Licensed CC0.

---

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