Surgify Halo recall
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Why was Surgify Halo recalled?
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 06429811532120 ; All lots until the IFU update has been implemented
- Product
- Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
- Recalling firm
- SURGIFY MEDICAL OY
- Quantity
- N/A
- Distribution
- US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
- Recall date
- July 1, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)