Surgify Halo surgical burr recalled for potential breakage risk
Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.
What this means for you
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: This is an FDA Class II recall involving a risk-of-harm device (surgical burr breakage during spinal surgery could impede the procedure or cause patient harm). The source text does not report any illnesses or injuries, so per the rubric, the score does not exceed 3.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 4.0 mm, Short (Model/Catalog Number: 40.070.NVG.H1) due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS).
The recalled device is a surgical drill, burr, trephine, and accessory (simple, powered) with UDI 06429811532069. All lots are affected until the Instructions for Use (IFU) update has been implemented.
The device has been distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. Users who have this device should contact Surgify Medical OY for guidance on the recall.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
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)
- UDI06429811532069
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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