Velys Enabling Tech Robotic-Assist Station REF: 451611001
FDA Recall Z-3088-2026 · Posted 2026-09-02
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Recalling FirmMedos International Sarl
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2026-07-23
Product Quantity29 stations
Reason for Recall
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Firm Action
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
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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