Restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR

Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.

On 7/28/2026, recall notices were emailed to customers who were asked to do the following: 1) Segregate and return affected devices. 2) Complete and return the response form. If additional questions, contact firm at 984-201-2310

• FDA enforcement recordOfficial FDA database entry for Z-3178-2026
• FDA 510(k) clearance · K223326The device's official FDA premarket clearance record
• FDA device classification · OYKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3110The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find restor3d Inc.Search 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.