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 | Completed |
| Reason | The wrong tibia guide was included intended for a different patient case. |
| Product | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01 |
| Quantity | 2 Guides |
| Distribution | International Distribution to countries of: Germany, Netherlands |
| Initiated | 2023-04-26 |
| Classified | 2023-07-20 |
| Recall number | Z-2213-2023 |
| 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-2213-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92621/
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