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Surgify Medical Oy FDA Recalls
19 recalls on file across devices, 0 of them Class I and 19 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, pClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powereClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, poweredClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powereClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, poweredClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, pClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powereClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)Class IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accessories (simple, powereClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powereClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)Class IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, pClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powerClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powereClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, poweredClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, pClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, pClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, poweredClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |
| Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, poweredClass IIApr 30, 2026Potential for burr breakage, occurring during bi-portal endo |