Surgify Halo Surgical Burr May Break During Spinal Surgery
Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The recalled burrs have UDI 06429811532335 and were 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: This is an FDA Class II recall involving a surgical device with potential for harm during a critical procedure. Although no injuries have been reported in the source text, the risk of burr breakage during spinal surgery—where retained fragments could cause serious complications—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 surgical burr (Model/Catalog Number 54.140.SHD.U1) due to a potential for burr breakage during bi-portal endoscopic spinal surgery (BESS). The defect affects all lots of this burr model until the Instructions for Use (IFU) update has been implemented.
The recalled product was distributed nationwide in the states of Minnesota, Massachusetts, Indiana, Louisiana, California, New York, and Florida. Affected users can identify recalled units by the UDI 06429811532335.
Healthcare providers and facilities using this burr should discontinue use and contact Surgify Medical OY for information about the IFU update or a replacement product. Burr breakage during surgery could result in fragments remaining in the surgical site, requiring additional intervention.
The recalled product
- Product
- Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.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: 06429811532335
- 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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