Materialise N.V.
Complete recall history across all FDA and CPSC categories — 7 total recalls
Materialise N.V. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (7)
FDA medical device enforcement actions by Materialise N.V.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 19, 2023 | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to gui... | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to ... | Class II |
| Apr 26, 2023 | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... | The wrong tibia guide was included intended for a different patient case. | Class II |
| Jul 17, 2020 | Match Point System The Match Point System is intended to by uses as a surg... | The procedure side indicated in the top header of the Shoulder Case Planning ... | Class II |
| Feb 3, 2020 | TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD... | Custom surgical kits contain a plate different than indicated by the package ... | Class II |
| Feb 3, 2020 | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 | Custom surgical kits contain a plate different than indicated by the package ... | Class II |
| Sep 23, 2015 | Signature Patient-Specific Surgical Guides; patient specific instruments used... | Potential inaccuracies in the alignment of the guides. Surgery was inaccurat... | Class II |
| Feb 4, 2015 | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Spec... | Images belonging to a different patient were used for the production of the p... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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