Surgify Halo surgical burr recalled for potential breakage during spinal surgery
Surgify Halo 40 mm surgical burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially creating risks during the procedure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where the hazard involves potential device failure (burr breakage) during a surgical procedure. No reported injuries are mentioned in the source, but the risk of harm from a broken surgical instrument during active spinal surgery qualifies as High per the rubric criterion for risk-of-harm products.
Plain-English summary
SURGIFY MEDICAL OY is recalling the Surgify Halo, 40 mm, Long surgical burr (Model/Catalog Number: 40.125.NVG.U1, UDI: 06429811532274). The recall includes all lots until the Instructions for Use (IFU) update has been implemented. The burr may break during bi-portal endoscopic spinal surgery (BESS).
The product was distributed nationwide to medical facilities in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. This is a Class II recall.
Physicians and healthcare facilities using this product should stop use, consult the FDA notice for additional details, and contact the manufacturer or their distributor for guidance on replacement products or IFU updates. Patients who have undergone or are scheduled for BESS procedures using this burr should consult their surgeon.
The recalled product
- Product
- Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 06429811532274
- All lots until the IFU update has been implemented
Distribution
Part of a larger recall action
This product is one of 19 recalled by SURGIFY MEDICAL OY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · SURGIFY MEDICAL OY
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