DeviceClearance

Z-1769-2026

Class II · Ongoing

Recalling firm
Tornier, Inc
Classification
Class II
Status
Ongoing
Initiated
20260305
Firm location
Bloomington, MN, United States

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.