Surgify Halo surgical drill recalled for potential burr breakage
Surgify Halo 3.0 mm surgical drills may experience burr breakage during bi-portal endoscopic spinal surgery. The FDA is requesting the recall of this device across multiple US 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 device with a risk-of-harm hazard (burr breakage during spinal surgery) where no reported injuries are stated in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 3.0 mm, Long (Model/Catalog Number: 30.125.NVG.U2) due to a potential for burr breakage that may occur during bi-portal endoscopic spinal surgery (BESS).
The recalled drills, burrs, trephines, and accessories are simple, powered surgical instruments. All lots are affected until the Instruction For Use (IFU) update has been implemented. The device is identified by UDI: 06429811532212.
The product has been distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. Healthcare facilities and surgical centers in these areas that possess this device should contact the manufacturer or consult the FDA recall notice for instructions on how to proceed.
The recalled product
- Product
- Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
- surgical-device-failure
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: 06429811532212
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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