Surgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use
Surgify Halo 4.0 mm Short burrs may break during bi-portal endoscopic spinal surgery, creating a potential hazard during the procedure. The FDA has classified this as a Class II recall affecting devices 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 product (burr breakage during spinal surgery could cause serious injury). The source text does not report any actual injuries or illnesses, making this a theoretical hazard scenario, which aligns with a High severity classification.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 4.0 mm, Short (Model/Catalog Number: 40.070.NVG.U1) due to the potential for burr breakage occurring during bi-portal endoscopic spinal surgery (BESS). The recalled device is a powered surgical burr used in spinal procedures.
The affected devices were distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The recall includes all lots until the Instructions for Use (IFU) update has been implemented. The device can be identified by UDI: 06429811532267.
Surgeons and surgical facilities using this device should stop use of affected lots and contact Surgify Medical OY for further guidance. Healthcare providers should review their inventory of Surgify Halo 4.0 mm Short burrs to identify and quarantine recalled units. Patients who have undergone bi-portal endoscopic spinal surgery with this device should contact their surgeon if they have concerns.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
- surgical-hazard
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: 06429811532267
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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