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 | Terminated |
| Reason | Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. |
| Product | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. |
| Quantity | 1 |
| Distribution | Distributed in Canada. |
| Initiated | 2013-11-08 |
| Classified | 2013-12-26 |
| Terminated | 2014-01-07 |
| Recall number | Z-0577-2014 |
| 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-0577-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66935/
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