Materialise TRUMATCH Orthognathic Kit Recall: Custom Plate Risk

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Recalling firmMaterialise N.V.Technologielaan 15 · Heverlee, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Materialise is recalling TRUMATCH Orthognathic Full Bimaxillary Surgical Kits because the surgical plate in some kits differs from what's labeled on the package. This could lead to incorrect surgical procedures if the wrong plate is used.

Why it’s dangerous

The recall states that custom surgical kits contain a plate different than indicated by the package labeling. This mismatch could cause incorrect surgical procedures if the wrong plate is used during operations.

Who’s affected

Surgical teams using the TRUMATCH Orthogn: Full Bimaxillary Surgical Kit (Catalog SD980.001) are likely affected. Surgeons and dental professionals who have purchased this specific kit are at highest risk.

How to tell if you have this one

Check for the catalog number SD980.001 on the kit packaging. The lot number MU20VAFVEK and UDI (01)05420060380013(10)MU20VAFVEK are also associated with this specific recall.

Brand
Materialise
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Labeling
Verify the catalog number on the kit packaging to confirm if it matches SD980.001.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The recall states that custom surgical kits contain a plate different than indicated by the package labeling.

What should I do if I have this kit?

The official notice does not specify a remedy for this recall.

How can I tell if my kit is affected?

Check for the catalog number SD980.001 on the kit packaging. The lot number MU20VAFVEK and UDI (01)05420060380013(10)MU20VAFVEK are also associated with this specific recall.

Take action

Contact Materialise

We’ve drafted a message you can send Materialise to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1484-2020 — Materialise Materialise

Hello,

I own a Materialise that is covered by recall Z-1484-2020 from Materialise.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1484-2020 (February 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1484-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Materialise N.V. recalls TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

Recall notice