Facility

SURGIFY MEDICAL OY

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3015392173
Establishment type	Manufacture Medical Device
Location	Otakaari 5 I Espoo Uusimaa, FI 02150
Registration status	Active · expires 2026
Parent company	Surgify Medical Oy (owner-operator 10090633)

Activity by year

Recalls (1)

Devices registered here (1)

Drills, Burrs, Trephines & Accessories (Simple, Powered)
Product code HBE (opens in a new tab) · Class II · Neurology · 21 CFR 882.4310

Recalls & enforcement

Class IIOngoing2026-04-30
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

All facilities operated by Surgify Medical Oy

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SURGIFY MEDICAL OY (FEI 3015392173) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015392173-surgify-medical-oy/

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