RegWardenFDA facility compliance records
Company

MATERIALISE N.V.

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

Recalls by year

FDA actions on record by year2013: 2 recalls; 2014: 1 recalls; 2015: 2 recalls; 2016: 1 recalls; 2020: 2 recalls; 2022: 1 recalls; 2023: 2 recalls2’131’142’151’16’17’18’192’20’211’222’23’24’25’26
  • Recalls (11)

Registered facilities (7)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “MATERIALISE N.V. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9029485-materialise-n-v/

Not open yet

Alerts for MATERIALISE N.V.

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.