{"url_path":"/fda/device/recalls/Z-2571-2026","section_key":"summary","section_title":"DEVICE Recall: SURGIFY MEDICAL OY — Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-30","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2571-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"SURGIFY MEDICAL OY"},"word_count":85,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2571-2026\n\n**Recalling firm:** SURGIFY MEDICAL OY\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-30\n**Report date:** 2026-07-01\n\n## Product\nSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)\n\n## Reason\nPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).\n\n## Affected lots\nUDI: 06429811532304 ; All lots until the IFU update has been implemented\n\n## Distribution\nUS Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL."}