Facility

I.T.S. GMBH

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

Key facts

2recalls · worst Class II

2inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	3004369035
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	AUTAL 28 LASSNITZHOEHE Steiermark, AT A-8301
Registration status	Active · expires 2026
Parent company	I.T.S. GmbH (owner-operator 9059922)

Activity by year

Recalls (2)
Inspections (2)
Warning letters (1)

Devices registered here (2)

Rod, Fixation, Intramedullary And Accessories
Product code HSB (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3020
Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

Class IIOngoing2026-01-23
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Class IIOngoing2019-05-09
The titanium implant has the wrong article number laser marked on it.

FDA inspections (2)

OAI2023-01-19
Official Action Indicated · Compliance: Devices · citations posted
VAI2019-05-03
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2024-03-15
Warning Letter (opens in a new tab) · Lasnitzhohe

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by I.T.S. GmbH

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. “I.T.S. GMBH (FEI 3004369035) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004369035-i-t-s-gmbh/

Not open yet

Alerts for I.T.S. GMBH

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.