Materialise N.V.
Country not established FDA establishment FEI 3003998208
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 7
Company details
- FDA FEI number
- 3003998208
- Address
- 15 TECHNOLOGIELAAN, LEUVEN Vlaams Brabant
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 3
- 2021 0
- 2022 0
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 19 Jun 2023 Z-2287-2023 Class II Completed Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
- 26 Apr 2023 Z-2213-2023 Class II Completed The wrong tibia guide was included intended for a different patient case.
2020
- 17 Jul 2020 Z-2886-2020 Class II Terminated 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.
- 3 Feb 2020 Z-1484-2020 Class II Terminated Custom surgical kits contain a plate different than indicated by the package labeling.
- 3 Feb 2020 Z-1485-2020 Class II Terminated Custom surgical kits contain a plate different than indicated by the package labeling.
2015
- 23 Sep 2015 Z-0162-2016 Class II Terminated Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
- 4 Feb 2015 Z-1287-2015 Class II Terminated 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.