Z-3088-2026Class II

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Name: Z-3088-2026 Velys Enabling Tech Robotic-Assist Station REF: 451611001
Creator: Medos International Sarl
Published: 2026-07-23
License: https://open.fda.gov/license/

Medos International SARL / initiated 2026-07-23 / Open, Classified / root cause: software

FDA source

Medos International Sarl began a recall of Velys Enabling Tech Robotic-Assist Station REF: 451611001 on 2026-07-23. The reason FDA records is "Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3088-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-23
Posted: 2026-09-02
Recalling firm: Medos International SARL
Product: Velys Enabling Tech Robotic-Assist Station REF: 451611001
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Root cause tag: software
FDA root cause: Under Investigation by 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
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3088-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3088-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-09-02

Product code OLO

K233228Class IISpine Navigation and Robotic-Assistance DeviceEcential Robotics / cleared 2024-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)