Recall Z-1651-2025— Tornier, Inc

Name: FDA recall Z-1651-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-03

Class II · Ongoing

Class II FDA medical device recall by Tornier, Inc, initiated 2025-03-03. It names one FDA 510(k) clearance: K100562. Product: stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented. Reason: 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).

Recalling firm: Tornier, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-03-03
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K100562 — LATITUDE ELBOW PROSTHESISTornier, Inc.·cleared 2010-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.