FDAFDA recall Z-3088-2026 · Sep 9, 2026
Medos International Sarl: Velys Enabling Tech Robotic-Assist Station REF: 451611001 recall
Recall found
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- 29 stations
- Distribution
- US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
- Recalling firm
- Medos International Sarl, Le Locle, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-23
Source: openFDA enforcement record Z-3088-2026 · search recall number Z-3088-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.