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Velys Enabling Tech Robotic-Assist Station REF: 451611001

Class II
Recalling firm
Medos International Sarl
Reason for recall
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Affected products (lot / model / serial)
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
Units affected
29 stations
Distribution pattern
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Firm location
Le Locle, N/A, Switzerland
Recall type
Voluntary: Firm initiated
How the firm notified customers
Visit
Product type
Devices
Status
Ongoing
Recall number
Z-3088-2026
Recall initiated
July 23, 2026
FDA classification date
September 2, 2026
FDA report date
September 9, 2026
FDA event ID
99467
Last updated on HTM Vibe
September 15, 2026
View on openFDA