Recall Z-3088-2026— Medos International Sarl

Name: FDA recall Z-3088-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Class II · Ongoing

Class II FDA medical device recall by Medos International Sarl, initiated 2026-07-23. It names one FDA 510(k) clearance: K233228. Product: Velys Enabling Tech Robotic-Assist Station REF: 451611001. Reason: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning..

Recalling firm: Medos International Sarl
Classification: Class II
Status: Ongoing
Initiated: 2026-07-23
Firm location: Le Locle, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K233228 — Spine Navigation and Robotic-Assistance DeviceEcential Robotics·cleared 2024-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.