Z-3088-2026 Class II Ongoing
FDA device recall Z-3088-2026 was initiated by Medos International Sarl on July 23, 2026 and is designated Class II. Reason for recall: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. The recall status is ongoing. Affected quantity: 29 stations.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 stations
Product Description
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.
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.
Code Information
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