Surgify Halo Surgical Burr Recalling Potential Tool Breakage Risk
SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed 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 for a surgical device with potential for breakage during use, which poses a risk of harm (tool fragment retention in surgical field) in a high-risk procedure. No injuries or illnesses are reported in the source text, but the hazard is directly stated and applies to active surgical use.
Plain-English summary
SURGIFY MEDICAL OY is recalling the Surgify Halo, 5.4 mm, Extendable (Model/Catalog Number: 54.000.SEE.U1), a powered surgical drilling and cutting tool used in spine surgery. The recall has been issued because the burr component has the potential to break during bi-portal endoscopic spinal surgery (BESS) procedures.
The recalled product, with UDI 06429811532311, has been distributed nationwide across the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. All lots are affected until the Instructions for Use (IFU) have been updated.
If you have received or used this product, contact SURGIFY MEDICAL OY immediately for instructions on how to proceed. Do not use the product until further notice.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
- Hazard
- burr-breakage
- tool-fragmentation
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: 06429811532311
- All lots until the IFU update has been implemented
Distribution
Distributed nationwide across the United States.
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