Materialise N.V. FDA Record
Materialise N.V. has 7 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Materialise N.V." is on file.
- Latest recall
- Z-2287-2023 · Class II · Jun 19, 2023
- Latest inspection
- Mar 13, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 7 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 2 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 3 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2287-2023 | Class II | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone… | Jun 19, 2023 |
| Z-2213-2023 | Class II | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)… | Apr 26, 2023 |
| Z-2886-2020 | Class II | Match Point System The Match Point System is intended to by uses as a surgical instrument to… | Jul 17, 2020 |
| Z-1485-2020 | Class II | TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 | Feb 3, 2020 |
| Z-1484-2020 | Class II | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 | Feb 3, 2020 |
| Z-0162-2016 | Class II | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during… | Sep 23, 2015 |
| Z-1287-2015 | Class II | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides… | Feb 4, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 13, 2025 | Leuven, Belgium | Devices | Voluntary Action Indicated (VAI) | 3003998208 |
| Feb 2, 2017 | Leuven, Belgium | Devices | No Action Indicated (NAI) | 3003998208 |
| Feb 6, 2014 | Leuven, Belgium | Devices | Voluntary Action Indicated (VAI) | 3003998208 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003998208 | Leuven, Belgium | 3 | Mar 13, 2025 |
Materialise N.V. and the FDA: common questions
Has Materialise N.V. received an FDA warning letter?
No FDA warning letter addressed to the name "Materialise N.V." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Materialise N.V. received an FDA Form 483?
FDA has not published a Form 483 for "Materialise N.V." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Materialise N.V.?
The most recent FDA inspection on file ended Mar 13, 2025 at Leuven, Belgium and was classified VAI. FDA has 3 inspections of Materialise N.V. on file.
Has Materialise N.V. had an FDA recall?
Yes. Materialise N.V. has 7 FDA recalls on record. The most recent started Jun 19, 2023.
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