Recall Z-2563-2026 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
SURGIFY MEDICAL OY
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
| Date | Jun 24, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). |
| Root cause | Under Investigation by firm |
| Action | 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. Speci |
| Quantity | 0 |
| Distribution | US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Medical OY, Mar 26, 2026 |