Surgify Halo spinal surgery burr tool potential breakage recall
Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.
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 product (burr breakage in spinal surgery could cause serious patient injury), and no reported illnesses or injuries are stated in the source. Per the rubric, such risk-of-harm products without reported injury qualify as High (score 3).
Plain-English summary
SURGIFY MEDICAL OY is recalling the Surgify Halo, 4.0 mm, Extendable (Model/Catalog Number: 40.000.SEE.U1) due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). The burr is a powered surgical tool used in spinal procedures.
The recall affects units distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. All lots are affected until an Instructional For Use (IFU) update has been implemented. The device is identified by UDI 06429811532281.
If you are using or have used this device, contact SURGIFY MEDICAL OY for guidance on the IFU update and safe use going forward.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
- surgical-complication
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: 06429811532281
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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