Facility

Materialise Ukraine, Rep. office

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

Key facts

11recalls · 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)	3009555440
Establishment type	Manufacture Medical Device
Location	Raisy Okipnoy str., 8A Kyiv Kyyiv, Misto, UA 02002
Registration status	Active · expires 2026
Parent company	MATERIALISE N.V. (owner-operator 9029485)
Brand names	Mimics Cardiac Planner

Activity by year

Recalls (11)

Devices registered here (1)

System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IICompleted2023-06-19
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Class IICompleted2023-04-26
The wrong tibia guide was included intended for a different patient case.
Class IICompleted2022-07-13
MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
Class IITerminated2020-07-17
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
Class IITerminated2020-02-03
Custom surgical kits contain a plate different than indicated by the package labeling.
Class IITerminated2016-05-03
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper …
Class IITerminated2015-09-23
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Class IITerminated2015-02-04
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
Class IITerminated2014-10-16
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over speci…
Class IITerminated2013-11-26
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Class IITerminated2013-11-08
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

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. “Materialise Ukraine, Rep. office (FEI 3009555440) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009555440-materialise-ukraine-rep-office/

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