Surgify Halo spinal surgery burr tool potential breakage recall
Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.
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: This is an FDA Class II recall involving a risk-of-harm product (burr breakage in spinal surgery could cause serious patient injury), and no reported illnesses or injuries are stated in the source. Per the rubric, such risk-of-harm products without reported injury qualify as High (score 3).
Plain-English summary
SURGIFY MEDICAL OY is recalling the Surgify Halo, 4.0 mm, Extendable (Model/Catalog Number: 40.000.SEE.U1) due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). The burr is a powered surgical tool used in spinal procedures.
The recall affects units distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. All lots are affected until an Instructional For Use (IFU) update has been implemented. The device is identified by UDI 06429811532281.
If you are using or have used this device, contact SURGIFY MEDICAL OY for guidance on the IFU update and safe use going forward.
The recalled product
- Product
- Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.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: 06429811532281
- 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
See all →- HighSurgify Halo surgical drill may break during spinal surgery procedures
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- HighSurgify Halo Spinal Surgery Burrs Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill equipment recalled for potential burr breakage
FDA (Devices) · 2026-07-01
Same hazard · burr breakage
See all →- HighSurgify Halo surgical burrs recalled for potential breakage
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burrs recalled for potential breakage during spinal surgery
FDA (Devices) · 2026-07-01
- HighSurgify Halo 4.0 mm Spinal Surgery Burrs May Break During Use
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalling Potential Tool Breakage Risk
FDA (Devices) · 2026-07-01
Similar recalls
- HighStryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery
FDA (Devices) · 2024-09-04
- HighStryker iBur Surgical Bur Recall Due to Excessive Heat Risk
FDA (Devices) · 2024-09-04
- HighStryker iBur Surgical Bur Recalled Due to Excessive Temperature Risk
FDA (Devices) · 2024-09-04
- HighIn2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
FDA (Devices) · 2021-03-31
- SevereAesculap Flexible Drill Recalled Due to Potential Shaft Breakage During Surgery
FDA (Devices) · 2015-12-30
- ModerateStryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise
FDA (Devices) · 2018-09-05