FDA recall Z-3088-2026

Medos International Sarl · Class II · device

Product

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

US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.

Key facts

Status
Ongoing
Initiation date
2026-07-23
Report date
2026-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Le Locle, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3088-2026