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

Medical DevicesSource: FDA (device) · Date: 2026-09-09

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medos International Sarl
Product
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Reason / hazard
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Recall initiated
2026-07-23
Code info
UDI: 10705034645995/Serial Numbers: W14316295301 W15316297501 W15316298001 W17316322901 W17316323301 W21316347401 W21316347501 W21316347601 W21316347801 W21316347901 W21316348001 W22316365801 W34316479001 W34316479101 W34316479201 W34316479301 W34316479401 W34316479601 W34316479801 W34316480001 W34316480101 W49316554301 W51316597001 W51316597101 Y03316603601 Y03316603701 Y03316603801 Y07316625901 Y15316690901
Product quantity
29 stations
Voluntary mandated
Voluntary: Firm initiated
City
Le Locle
State
N/A
Country
Switzerland
Event id
99467
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