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 | The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification. |
| Product | Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. |
| Quantity | 1 |
| Distribution | Nationwide Distribution to MN only |
| Initiated | 2014-10-16 |
| Classified | 2014-11-21 |
| Terminated | 2015-02-17 |
| Recall number | Z-0418-2015 |
| 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-0418-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69632/
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