MATERIALISE N.V. FDA Inspection Record
MATERIALISE N.V. is an FDA-registered facility (FEI 3003998208) located in LEUVEN Vlaams Brabant, BE. RegDataLab tracks 3 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Mar 13, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 6, latest Jun 19, 2023
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 13, 2025 | Voluntary Action Indicated (VAI) | Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Feb 2, 2017 | No Action Indicated (NAI) | No citations listed |
| Feb 6, 2014 | Voluntary Action Indicated (VAI) | Records of complaint investigation (21 CFR 820.198(e)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 19, 2023 | Class II | Z-2287-2023 | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the… Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request |
| Apr 26, 2023 | Class II | Z-2213-2023 | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific… The wrong tibia guide was included intended for a different patient case. |
| Jul 17, 2020 | Class II | Z-2886-2020 | Match Point System
The Match Point System is intended to by uses as a surgical… The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for… |
| Feb 3, 2020 | Class II | Z-1484-2020 | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 and 1 more product Custom surgical kits contain a plate different than indicated by the package labeling. |
| Sep 23, 2015 | Class II | Z-0162-2016 | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide… Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly… |
| Feb 4, 2015 | Class II | Z-1287-2015 | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia)
The Signature Patient-Specific Surgical… Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause… |
FDA record score
13 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
8 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Mar 13, 2025 | 6 x 1 | 6 |
| Class II recall Z-2287-2023, this FEI as the recalling firm | Jun 19, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-2213-2023, this FEI as the recalling firm | Apr 26, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-2886-2020, this FEI as the recalling firm | Jul 17, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-1484-2020, this FEI as the recalling firm | Feb 3, 2020 | 4 x 0.25 | 1 |
| Class II recall Z-0162-2016, this FEI as the recalling firm | Sep 23, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1287-2015, this FEI as the recalling firm | Feb 4, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Feb 6, 2014 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Materialise N.V.
- Location
- LEUVEN Vlaams Brabant (BE)
- Source
- device