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 | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used. |
| Product | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. |
| Quantity | 1 |
| Distribution | One consignee, Indiana. |
| Initiated | 2016-05-03 |
| Classified | 2016-06-09 |
| Terminated | 2016-06-28 |
| Recall number | Z-1941-2016 |
| 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-1941-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74213/
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