United StatesSurgify Halo drills, burrs, trephines and related powered accessories (including multiple Surgify Halo models such as 3.0 mm, 4.0 mm and 5.4 mm with listed model/catalog numbers and UDIs), all lots until the IFU update has been implemented, are affected. They were recalled because of a potential for burr breakage during bi‑portal endoscopic spinal surgery (BESS).
What's being recalled
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
And 4 more products.
Recalling firm: Surgify Medical Oy, Espoo, N/A, Finland.
How to identify it
UDI: 06429811532229; All lots until the IFU update has been implemented UDI: 06429811532205; All lots until the IFU update has been implemented UDI: 06429811532212; All lots until the IFU update has been implemented UDI: 06429811532076; All lots until the IFU update has been implemented UDI: 06429811532281; All lots until the IFU update has been implemented UDI06429811532069; All lots until the IFU update has been implemented UDI: 06429811532267; All lots until the IFU update has been implemented UDI: 06429811532083; All lots until the IFU update has been implemented UDI: 06429811532274; All lots until the IFU update has been implemented UDI: 06429830116998 ; All lots until the IFU update has been implemented UDI: 06429811532311 ; All lots until the IFU update has been implemented UDI: 06429811532090 ; All lots until the IFU update has been implemented UDI: 06429811532298 ; All lots until the IFU update has been implemented UDI: 06429811532120 ; All lots until the IFU update has been implemented UDI: 06429811532328 ; All lots until the IFU update has been implemented UDI: 06429811532106 ; All lots until the IFU update has been implemented UDI: 06429811532304 ; All lots until the IFU update has been implemented UDI: 06429811532137 ; All lots until the IFU update has been implemented UDI: 06429811532335 ; All lots until the IFU update has been implemented
The hazard
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)