Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

stryker Latitude EV HUMERAL REVISION STEM TRIAL Recalled by Tornier, Inc Due to A specific lot of Latitude Humeral Trial Stems...

Date: March 3, 2025
Company: Tornier, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tornier, Inc directly.

Affected Products

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

Quantity: 5 units

Why Was This Recalled?

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)

Where Was This Sold?

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

About Tornier, Inc

Tornier, Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report