Materialise USA LLC: FDA recalls

FDA enforcement reports name Materialise USA LLC as the recalling firm in 5 events. The events have 6 product records. The recalls started from 2013 to 2022. All the events are device recalls.

See the 5 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

5 events, newest first.

FDA enforcement events of Materialise USA LLC
Initiated	Product (first record)	Type	Class	Records	Status
13 Jul 2022	ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208	Device	Class II	1	Completed
3 May 2016	Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.	Device	Class II	1	Terminated
16 Oct 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 positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and…	Device	Class II	1	Terminated
26 Nov 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 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…	Device	Class II	1	Terminated
8 Nov 2013	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.	Device	Class II	2	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Materialise USA LLC: events for each product type
Type		Events
Device		5

Materialise USA LLC: events in each class
Class		Events
Class II		5

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Materialise USA LLC, by the year that the recall started. The largest year is 2013, with 2 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Materialise USA LLC: FDA recalls. https://recallregister.com/firm/materialise-usa-llc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MI

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Materialise USA LLC have?: Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Materialise USA LLC?: FDA event 90704, which the firm started on 13 Jul 2022. The first product in the record is: ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
How many FDA recalls of Materialise USA LLC have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.