Recall Z-1769-2026— Tornier, Inc

Name: FDA recall Z-1769-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-05

Class II · Ongoing

Class II FDA medical device recall by Tornier, Inc, initiated 2026-03-05. It names one FDA 510(k) clearance: K251686. Product: Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252. Reason: Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-03-05
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.·cleared 2025-10-30

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

Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

Reason for recall

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

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