The Recall Desk

Manufacturer

Materialise USA LLC

6 recalls in our database name Materialise USA LLC as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2022-08-31

Of the 6 recalls from Materialise USA LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Devices)·Z-1569-2022·2022-08-31

    Anatomical Model Recalled for Wrong Product Shipped in Packaging

    Materialise USA LLC is recalling ProPlan CMF Anatomical Model units where packages labeled MU22-INA-DUQ contained the wrong anatomical model inside. Recipients should verify their package contents match the label.

    Product
    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2016·2016-06-15

    Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error

    Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.

    Product
    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0418-2015·2014-12-03

    Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides

    Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.

    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 l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2014·2014-01-15

    Materialise Recalls Shipped Femur Guide Due to Fit Conformance Issue

    Materialise USA LLC is recalling a specific lot of shipped femur guides from the Signature Personalized Patient Care System because a non-conformance could impact the fit of the drill insert.

    Product
    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-specifi
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0577-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
    Category
    Medical Device
    Distribution
    0 states