Surgify Halo Surgical Burr Recalled for Breakage Risk
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA is recalling this device nationwide due to the potential breakage hazard.
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 potential for breakage during a delicate spinal procedure. Although no injuries or illnesses are reported in the source, the risk-of-harm scenario involving surgical equipment in a sensitive anatomical location meets the High severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo 5.4 mm, Long burr (Model/Catalog Number 54.140.SHD.H1) nationwide. The device has a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS).
The recall affects all lots of this surgical burr in the United States, with distribution reported in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The affected device is identified by UDI 06429811532137.
Healthcare facilities and surgeons using this device should cease use and contact the manufacturer. The recalling firm is working to implement an updated Instruction for Use (IFU) to address the breakage issue.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- device-breakage
- surgical-injury-risk
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: 06429811532137
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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