{"url_path":"/fda/device/recalls/Z-3088-2026","section_key":"summary","section_title":"DEVICE Recall: Medos International Sarl — Velys Enabling Tech Robotic-Assist Station   REF: 451611001","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-23","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3088-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medos International Sarl"},"word_count":115,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3088-2026\n\n**Recalling firm:** Medos International Sarl\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-23\n**Report date:** 2026-09-09\n\n## Product\nVelys Enabling Tech Robotic-Assist Station   REF: 451611001\n\n## Reason\nSoftware issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.\n\n## Affected lots\nUDI: 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\n\n## Distribution\nUS Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA."}