Recall Z-3088-2026 ยท OLO Orthopedic Stereotaxic Instrument
Medos International Sarl
Velys Enabling Tech Robotic-Assist Station REF: 451611001
| Date | Sep 2, 2026 (initiated Jul 23, 2026) |
| Status | Open, Classified |
| Reason | Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 29 stations |
| Distribution | US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233228 | Spine Navigation and Robotic-Assistance Device Ecential Robotics, Jun 14, 2024 |