United StatesVelys Enabling Tech Robotic-Assist Station REF: 451611001 (UDI 10705034645995) is affected; units with the listed serial numbers distributed nationwide in the US are included in the recall. The firm recalled the devices because a software issue within the robotic controller may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
What's being recalled
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Recalling firm: Medos International Sarl, Le Locle, N/A, Switzerland.
How to identify it
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
The hazard
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)