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U.S. Department of Health and Human Services

Class 2 Device Recall Velys Enabling Tech RoboticAssist Station

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 Class 2 Device Recall Velys Enabling Tech RoboticAssist Stationsee related information
Date Initiated by FirmJuly 23, 2026
Date PostedSeptember 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3088-2026
Recall Event ID 99467
510(K)NumberK233228 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductVelys Enabling Tech Robotic-Assist Station REF: 451611001
Code Information 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
FEI Number 3008114965
Recalling Firm/
Manufacturer		 Medos International Sarl
Chemin Blanc 36
Le Locle Switzerland
For Additional Information ContactShannon Rook
+41 32 934 8472
Manufacturer Reason
for Recall		Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 OneMD-Field-Actions@its.jnj.com 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
Quantity in Commerce29 stations
DistributionUS Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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