Reported Sep 9, 2026 · Ongoing · Updated Sep 14, 2026

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Medos International Sarl

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medos International Sarl · Chemin Blanc 36 · Le Locle, N/A · N/A

Is this the product you have?

  • Velys Enabling
  • Tech Robotic-Assist Station REF451611001
Lot codes and dates
  • UDI10705034645995/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
Amount recalled
29 stations

Where it was sold

Why it was recalled

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 2:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.