Materialise USA, LLC.

Activity by year

Devices registered here (5)

• Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  Product code JWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
  Product code HRY (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3530
• Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
  Product code MBH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3565
• Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
  Product code OIY (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560
• Knee Arthroplasty Implantation System
  Product code OOG (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560

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.

FDA inspections (2)

• VAI2021-10-06
  Voluntary Action Indicated · Compliance: Devices · citations posted
• NAI2017-08-01
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

Related

• All facilities operated by MATERIALISE N.V.
• Materialise Ukraine, Rep. office (UA)
• Materialise Colombia S.A.S (CO)
• MATERIALISE N.V. (BE)
• Materialise S.A. (PL)
• Materialise Motion N.V. (BE)
• Materialise Sdn Bhd (MY)

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)