Summary
The FDA issued a Class II for Velys Enabling Tech Robotic-Assist Station REF: 451611001 by Medos International Sarl. Reason: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning..
Details
Source
Device Recall
External ID
Z-3088-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Lot/Code Info: 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
Quantity Affected: 29 stations
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-23
Company
Le Locle, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Medos International Sarl has 23 FDA actions in our database, including 2 recalls and 21 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medos International Sarl) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medos International Sarl have FDA actions?
Medos International Sarl has 23 FDA actions in our database, including 2 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3088-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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