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Velys Enabling Tech Robotic-Assist Station REF: 451611001 recall

Medos International Sarl recalled Velys Enabling Tech Robotic-Assist Station REF: 451611001 on September 9, 2026 because of software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. It was sold nationwide.

Why it was recalled

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

What's recalled

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Quantity: 29 stations

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Medos International Sarl, Le Locle, N/A
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Status
Ongoing
Recall number
Z-3088-2026
Source
U.S. Food and Drug Administration

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