Class II — Materialise N.V.
| Recalling firm | MATERIALISE N.V. |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Custom surgical kits contain a plate different than indicated by the package labeling. |
| Product | TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 |
| Quantity | 1 |
| Distribution | US: NY. OUS: Italy |
| Initiated | 2020-02-03 |
| Classified | 2020-03-13 |
| Terminated | 2020-03-20 |
| Recall number | Z-1485-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Materialise N.V. (Z-1485-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85080/
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