Medos International Sarl recalls Velys Enabling Tech Robotic-Assist Station REF: 451611001

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

On July 23, 2026, DePuy Synthes contacted affected consigenees via phone call concerning the recall. On July 24, 2026 Depuy issued a Urgent Medical Device Correction notification via sales associate visit. DePuy ask consignees to take the following actions: 1. Do not use the subject VELYS ROBOTIC-ASSIST STATION and quarantine it immediately. The VELYS. 2. Navigation Station and VELYS Camera Station can continue to be used following the Instructions for Use. 3. Complete, sign, and return the attached Business Response Form to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. 4. Forward this notice to anyone in your facility that needs to be informed 5. Post a copy of this notice in a visible area for awareness and keep a copy for your records. 6. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting Program Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reportingserious

• FDA enforcement recordOfficial FDA database entry for Z-3088-2026
• FDA 510(k) clearance · K233228The device's official FDA premarket clearance record
• FDA device classification · OLOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medos International SarlSearch 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.