Class II — Medos International Sarl
| Recalling firm | Medos International SARL |
|---|---|
| Registered facility | MEDOS INTERNATIONAL SARL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. |
| Product | Velys Enabling Tech Robotic-Assist Station REF: 451611001 |
| 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 | 2026-07-23 |
| Classified | 2026-09-02 |
| Recall number | Z-3088-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medos International Sarl (Z-3088-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99467/
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