Tornier, Inc recalls Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat

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.

On March 5, 2026, the firm notified affected customers of the product issue. Customers were instructed to locate affected product in their inventory. Relevant personnel should be informed that the affected product must not be used with Tornier HRS Max products, as they are incompatible. Product return is not necessary, but customers may contact the recalling firm to arrange for return if the product issue impacts their needs.

• FDA enforcement recordOfficial FDA database entry for Z-1769-2026
• FDA 510(k) clearance · K251686The device's official FDA premarket clearance record
• FDA device classification · KWSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tornier, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.