VELYS recallZ-3088-2026 · Medos International Sarl · initiated Jul 23, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medos International Sarl or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
FDA root cause category: Under Investigation by firm
What the company is doing
On July 23, 2026, DePuy Synthes contacted affected consigenees via phone call concerning the recall. On July 24, 2026 Depuy issued a Urgent Medical Device Correction notification via sales associate visit. DePuy ask consignees to take the following actions: 1. Do not use the subject VELYS ROBOTIC-ASSIST STATION and quarantine it immediately. The VELYS. 2. Navigation Station and VELYS Camera Station can continue to be used following the Instructions for Use. 3. Complete, sign, and return the attached Business Response Form to [email protected] within three (3) business days of receipt of this notification. 4. Forward this notice to anyone in your facility that needs to be informed 5. Post a copy of this notice in a visible area for awareness and keep a copy for your records. 6. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting Program Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reportingserious
Recall details
- Recall number
- Z-3088-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 23, 2026
- Posted by the FDA
- Sep 2, 2026
- Recalling firm
- Medos International Sarl
- Quantity
- 29 stations
- Product code
- OLO
- FDA submissions
- K233228
- Distribution
- US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Product description
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VELYS 451611000Medos International Sàrl · Orthopedic stereotaxic instrument1 recall25 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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