Device recall
Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Recall number
- Z-3088-2026
- Event id
- 99467
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medos International Sarl
- Report date
- Sep 9, 2026
- Posted
- Sep 2, 2026
- Initiated
- Jul 23, 2026
- Center classification date
- Sep 2, 2026
- Product code
- OLO
- Device type
- Orthopedic Stereotaxic Instrument
- Reason
- Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
- Root cause
- Under Investigation by firm
- Quantity
- 29 stations
- 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
- Distribution
- US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K233228
- Location
- Le Locle, N/A, Switzerland