The Recall Desk

Manufacturer

Materialise N.V.

7 recalls in our database name Materialise N.V. as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2023-08-09

Of the 7 recalls from Materialise N.V. 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.

1–7 of 7

  • HighFDA (Devices)·Z-2287-2023·2023-08-09

    ProPlan CMF Mandible Surgical Guides Recall for Wrong Version

    Materialise recalls ProPlan CMF mandible surgical guides because wrong versions were shipped prior to a redesign. Healthcare facilities should verify they have the correct version.

    Product
    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2023·2023-07-26

    MRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient

    Materialise N.V. is recalling MRI Biomet Pin Guides for total knee arthroplasty because the wrong patient-specific device was included in a shipment. Using an incompatible guide could affect surgical planning and implant placement.

    Product
    MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2886-2020·2020-09-02

    Match Point System surgical instrument recalled due to incorrect procedure side labeling

    The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.

    Product
    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1484-2020·2020-03-25

    Materialise Recalls TRUMATCH Orthognathic Surgical Kit Due to Labeling Error

    Materialise N.V. is recalling TRUMATCH Orthognathic surgical kits because the package labeling indicates a different plate than the one actually included.

    Product
    TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1485-2020·2020-03-25

    Materialise Recalls TRUMATCH Orthognathics Genioplasty Surgical Kit Due to Labeling Error

    Materialise N.V. is recalling TRUMATCH Orthognathics Genioplasty Surgical Kits because the package labeling indicates a different plate than the one actually contained in the kit.

    Product
    TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0162-2016·2015-11-04

    Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies

    Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.

    Product
    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.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1287-2015·2015-03-25

    Materialise Recalls Signature TKA Surgical Guides Due to Incorrect Patient Images

    Materialise N.V. is recalling Signature TKA GDE/MDL Set 04-05 surgical guides because images from a different patient were used for production.

    Product
    Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthr
    Category
    Medical Device
    Distribution
    0 states