PlainRecalls

Materialise USA LLC

Compiled from official public sources by the publisher.

6 recalls on record · Latest: Aug 31, 2022

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Agency notice ledger

Federal filing book Materialise USA LLC LIGHT-BOOK · SINGLE-AGENCY

#2,217 of 14,151 · 6 notices · 0.006% archive

  • BOOK 6 notices
  • RANK #2,217 of 14,151
  • SHARE 0.006% archive
  • AGENCY FDA Devices (6)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 31, 2022
  • PHOTO 1908 Brands

Nearest notice-volume peer: 1908 Brands (0 notice gap)

Materialise USA LLC accounts for about 0.006% of the 104,423-notice archive on 6 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Materialise USA LLC compares to 14,151 recalling firms

Materialise USA LLC ranks 2,217th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Materialise USA LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

6 2217th of 14151 higher than 11,804 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-19

Materialise USA LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Materialise USA LLC holds about 0.006% of archive notices alongside 6 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 31, 2022

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Devices Moderate Jun 15, 2016

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA Devices Moderate Dec 3, 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 positioning of the implant are identifiable on patient imaging scans.
FDA Devices Moderate Jan 15, 2014

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 Devices Moderate Jan 1, 2014

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. .
FDA Devices Moderate Jan 1, 2014

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.

Materialise USA LLC holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (6 here).

1908 Brands 6 Abbott Molecular 6 Accriva Diagnostics, Inc. 6 Advance Medical Designs, Inc. 6 Agave Dream 6

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Abbott Molecular 6 Accriva Diagnostics, Inc. 6 Advance Medical Designs, Inc. 6 American Medical Systems, Inc. 6

Frequently Asked Questions

How many federal recall notices name Materialise USA LLC? ▼
PlainRecalls indexes 6 distinct federal recall events naming Materialise USA LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Materialise USA LLC sit among other recalling firms? ▼
Materialise USA LLC ranks #2,217 of 14,151 by distinct recall-event count among 14,151 firms in this archive (83rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Materialise USA LLC's notices? ▼
FDA Devices accounts for 6 of this firm's 6 indexed notices.
What product category dominates Materialise USA LLC's filing book? ▼
Filings for Materialise USA LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Materialise USA LLC: 6 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Materialise USA LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026