Tornier, Inc recalls stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Se…

Recall date

March 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1651-2025

FDA classification

Class II

Brand / firm

Tornier, Inc

Sold / distributed

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

Why it was 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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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