FDA Device recall Z-3088-2026
Velys Enabling Tech Robotic-Assist Station REF: 451611001
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Velys Enabling Tech Robotic-Assist Station REF: 451611001 by Medos International Sarl, citing software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3088-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-23 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Medos International Sarl |
| Distribution | US |
Product
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Reason
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Identifiers
| code_info | UDI: 10705034645995/Serial Numbers: W14316295301 W15316297501 W15316298001 W17316322901 W17316323301 W21316347401 W2131…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3088-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.