Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of MaterialiseLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Materialise USA LLC with 6 device recalls. The most recent is a device recall dated Jul 13, 2022: ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 13, 2022 | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208Class II · MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK | Device recalls |
| May 3, 2016 | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.Class II · A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not | Device recalls |
| Oct 16, 2014 | Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the Class II · The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral gui | Device recalls |
| Nov 26, 2013 | REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA Class II · Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. | Device recalls |
| Nov 8, 2013 | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Class II · Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan inf | Device recalls |
| Nov 8, 2013 | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single UsClass II · Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan inf | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
