Class II — Materialise USA LLC
| 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 | Completed |
| Reason | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK |
| Product | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208 |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of MD. |
| Initiated | 2022-07-13 |
| Classified | 2022-08-24 |
| Recall number | Z-1569-2022 |
| 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 USA LLC (Z-1569-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90704/
Alerts for MATERIALISE N.V.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.