Reported Jul 1, 2026 · Ongoing
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple,…
Surgify Medical Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SURGIFY MEDICAL OY · Otakaari 5 I · Espoo, N/A · N/A
Is this the product you have?
- Surgify Halo, 5.4 mm, Long
- Model/Catalog Number54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
- Lot codes and dates
- UDI06429811532304 ; All lots until the IFU update has been implemented
- Amount recalled
- N/A
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
Why it was recalled
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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