Surgify Halo surgical burrs recalled for potential breakage
Surgify Halo 5.4 mm Short surgical burrs may break during bi-portal endoscopic spinal surgery. FDA Class II recall affects multiple U.S. states.
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 of a surgical instrument with a risk-of-harm hazard (burr breakage during spinal surgery). No reported injuries or hospitalizations are mentioned in the source text, placing it at the high end of High per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Surgify Medical OY is recalling Surgify Halo 5.4 mm Short burrs, Model/Catalog Number 54.070.NVG.U1, due to potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled product is identified by UDI 06429811532298 and includes all lots until the Instructions for Use (IFU) update has been implemented.
The recalled surgical burrs have been distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. This is an FDA Class II recall.
Surgeons and surgical facilities using this product should immediately discontinue use until the IFU update has been implemented. Facilities should review procedures with affected patients and consult the FDA guidance on this recall for additional instructions.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.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: 06429811532298
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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