Surgify Halo Surgical Burrs Subject to Potential Breakage Recall
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a surgical instrument with risk of harm (burr breakage during critical spine surgery), where no reported injuries are stated in the source text. Per the rubric, this qualifies as High severity—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 5.4 mm, Medium surgical burrs (Model/Catalog Number: 54.085.SHD.U1) due to a potential for burr breakage occurring during bi-portal endoscopic spinal surgery (BESS).
The affected devices have been distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. All lots are subject to recall until the Instruction for Use (IFU) has been updated. The devices are identified by UDI: 06429811532328.
Healthcare facilities and surgical professionals using this product should stop use of affected devices and contact Surgify Medical OY for guidance. Patients who have undergone BESS procedures with these burrs should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- SURGIFY MEDICAL OY
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: 06429811532328
- All lots until the IFU update has been implemented
Distribution
Part of a larger recall action
This product is one of 19 recalled by SURGIFY MEDICAL OY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 19 products in this recall →Related recalls
Same manufacturer · SURGIFY MEDICAL OY
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