SURGIFY MEDICAL OY recalls Surgify Halo

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)

Surgify issued a Medical Device Correction Notice - Surgify Halo - Restriction of Use notice to its consignees on 4/30/2026 via email. The notice explained the issue, potential risk, and requested the following: "What steps must the user take? Please review your current practice and ensure the device is only used in accordance with the updated safety information. Instruction to Customers: The customers have been instructed to do the following: - Do not use this device in endoscopic surgical procedures. If endoscopic access is required, an alternative instrument should be selected. Specifically: . Do not use this device in endoscopic surgical procedures. If endoscopic access is required, an alternative instrument should be selected. . Ensure that all relevant clinical staff and surgical team members are made aware of this notice. . Please retain this notice for your records and attach it to the relevant product documentation. Please acknowledge receipt of this Medical Device Correction Notice by replying to raqa@surgifymedical.com within 30 business days, confirming that the notice has been read, understood, and communicated to all relevant users within your organization. Please include your facility name, your name, and your role. If you have previously used the device in endoscopic procedures without incident, no patient follow-up is required; however, this application should now be discontinued in line with the updated safety information." For questions regarding this matter, please contact us by phone at +358 105 176 310 or via email at support@surgifymedical.com.

• FDA enforcement recordOfficial FDA database entry for Z-2555-2026
• FDA 510(k) clearance · K253627The device's official FDA premarket clearance record
• FDA device classification · HBEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4310The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SURGIFY MEDICAL OYSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.