Surgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
Surgify Medical is recalling Surgify Halo 4.0 mm Extendable surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The breakage could create a safety hazard during the procedure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving a surgical instrument used in spinal procedures. The potential for device breakage during surgery creates a risk of intraoperative complications and patient harm, meeting the Severe criteria for a Class II recall with risk of harm during an invasive procedure.
Plain-English summary
Surgify Medical OY is recalling Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number 40.000.SEE.H1 surgical burrs. The device may break during bi-portal endoscopic spinal surgery (BESS), which could create an unexpected hazard during the procedure.
This recall affects 112 units distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The affected devices are identified by UDI 06429811532076 and include all lots until the Instructions for Use (IFU) update has been implemented.
Healthcare facilities and surgical centers that use this device should stop using affected units immediately and contact Surgify Medical OY for further guidance. Surgeons and surgical teams should verify they are not using recalled units before performing bi-portal endoscopic spinal surgery procedures.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- device-breakage
- intraoperative-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: 06429811532076
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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