Surgify Halo Spinal Surgery Burrs Recalled for Breakage Risk
Surgify Medical is recalling Surgify Halo 5.4 mm Short burrs (Model 54.070.NVG.H1) due to potential breakage during bi-portal endoscopic spinal surgery. The hazard could affect patient safety during the procedure.
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 medical device recall with potential for harm (burr breakage during surgery) to patients. The source explicitly describes a mechanical failure risk during an active surgical procedure, which constitutes a risk-of-harm product. No reported injuries or adverse events are stated in the source text.
Plain-English summary
Surgify Medical OY is recalling the Surgify Halo, 5.4 mm, Short burr (Model/Catalog Number: 54.070.NVG.H1) and associated drills, trephines, and accessories. All lots are affected until the manufacturer updates the Instructions for Use (IFU).
The device has a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). This breakage could occur while the instrument is in use during the procedure.
The recalled devices have been distributed nationwide in Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. The device is identified by UDI 06429811532090. Healthcare facilities and surgeons using this product should contact Surgify Medical OY for guidance on the updated IFU and any additional instructions.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; 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: 06429811532090
- 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 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
- HighSurgify Halo surgical burrs recalled for potential breakage
FDA (Devices) · 2026-07-01
Same hazard · burr breakage
See all →- 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 spinal surgery burr tool potential breakage recall
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalling Potential Tool Breakage Risk
FDA (Devices) · 2026-07-01
Similar recalls
- HighIn2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
FDA (Devices) · 2021-03-31
- ModerateStryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise
FDA (Devices) · 2018-09-05
- SevereAnspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk
FDA (Devices) · 2012-08-01
- SevereSmith & Nephew BEAVER Blade 4.0mm Recalled for Fracture Risk
FDA (Devices) · 2016-02-17
- HighBiomet Compress Device Short Anchor Plug recalled due to metal burrs
FDA (Devices) · 2023-11-29
- ModerateStryker 5.0mm Barrel Bur Recall for Missing Notches
FDA (Devices) · 2014-06-18