FDA Medical Device Recalls (openFDA)
Medos International Sarl: Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Recall number
- Z-3088-2026
- Recalling firm
- Medos International Sarl
- Product
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Status
- Open, Classified
- Initiated
- 2026-07-23
- Posted
- 2026-09-02
- Terminated
- not on file
- Reason
- Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
- 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 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K233228"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3008114965
- Firm city
- Le Locle
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28