Class IIDeviceOngoing

Medos International Sarl

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.

Details

Recall number: Z-3088-2026
Event ID: 99467
Recall initiated: Jul 23, 2026
Classified: Sep 2, 2026
Reported: Sep 9, 2026
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Visit
Firm location: Le Locle, N/A, Switzerland
Lot / 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