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    Materialise USA, LLC.

    FDA registration
    Materialise USA, LLC.·27 products·🇺🇸 United States

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Recall
    Completed ·Materialise USA LLC·Product code HWT·July 13, 2022

    ZIMMER® PATIENT SPECIFIC INSTRUMENT

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code JWH·September 11, 2015

    SURGICASE

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code PBF·April 15, 2021

    TRUMATCH

    FDA Adverse Event
    Malfunction ·MATERIALISE USA LLC·Product code JEY·April 27, 2022

    MATERIALISE PERSONALIZED SOLUTION

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code PBF·May 22, 2024

    SURGICASE

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code PBF·June 2, 2022

    TRUMATCH CMF

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC.·Product code JEY·July 9, 2025

    TRUMATCH

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code HWT·July 6, 2022

    TRUMATCH

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code HWT·August 30, 2021

    TRUMATCH

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code JEY·December 7, 2023

    TRUMATCH

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code JEY·December 21, 2023

    PROPLAN CMF

    FDA Adverse Event
    Malfunction ·MATERIALISE USA LLC·Product code JEY·December 21, 2023

    TRUMATCH

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code JEY·February 6, 2025

    TRUMATCH

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code JEY·January 10, 2025

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    FDA Adverse Event
    Injury ·MATERIALISE USA LLC.·Product code HSX·May 5, 2015

    SURGICASE

    FDA Adverse Event
    Injury ·MATERIALISE USA, LLC·Product code PBF·November 22, 2019

    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

    FDA Recall
    Terminated ·Materialise N.V. 15 Technologielaan Heverlee Belgium·Product code OSF·September 23, 2015

    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 POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    FDA Recall
    Terminated ·Materialise USA LLC·Product code HRY·November 26, 2013

    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.

    FDA Recall
    Terminated ·Materialise USA LLC·Product code JWH·October 16, 2014