Surgify Halo Spinal Surgery Burrs Recalled for Breakage Risk
Surgify Medical is recalling Surgify Halo 5.4 mm Short burrs (Model 54.070.NVG.H1) due to potential breakage during bi-portal endoscopic spinal surgery. The hazard could affect patient safety during the procedure.
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 medical device recall with potential for harm (burr breakage during surgery) to patients. The source explicitly describes a mechanical failure risk during an active surgical procedure, which constitutes a risk-of-harm product. No reported injuries or adverse events are stated in the source text.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 5.4 mm, Short burr (Model/Catalog Number: 54.070.NVG.H1) and associated drills, trephines, and accessories. All lots are affected until the manufacturer updates the Instructions for Use (IFU).
The device has a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). This breakage could occur while the instrument is in use during the procedure.
The recalled devices have been distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The device is identified by UDI 06429811532090. Healthcare facilities and surgeons using this product should contact Surgify Medical OY for guidance on the updated IFU and any additional instructions.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
- surgical-instrument-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: 06429811532090
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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