Materialise TRUMATCH Genioplasty Kit Recall: Plate Mismatch 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 a specific add-on surgical kit for genioplasty procedures because the actual plate used differs from what's labeled on the packaging. This mismatch could lead to incorrect surgical procedures if the wrong plate is used during surgery.

Why it’s dangerous

The surgical kit contains a plate that does not match the specifications listed on the product packaging. This mismatch could result in using the wrong surgical component during procedures, potentially causing incorrect outcomes or complications.

Who’s affected

Surgical professionals using the TRUMATCH Orthognathics Genioplasty Surgical Kit add-on (Catalog Number SD980.013) are likely affected. Patients undergoing genioplasty procedures with this kit face the highest risk.

How to tell if you have this one

Check for the Catalog Number SD980.013 on the packaging. The affected units were sold with Lot Number ME19-ZIK-VIK and UDI (Unique Device Identification) (01)05420060380136(10)ME19ZIKVIK.

Brand
Materialise
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Labeling
Verify the Catalog Number SD980.013 on the packaging to confirm if the item is affected.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The recall is due to a plate in the surgical kit differing from what's labeled on the packaging.

What should I do if I have this kit?

The official recall notice does not specify a remedy or action steps for affected units.

Is there a risk of serious injury from this mismatch?

The recall record does not describe the potential for serious injury or harm.

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-1485-2020 — Materialise Materialise

Hello,

I own a Materialise that is covered by recall Z-1485-2020 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-1485-2020 (February 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1485-2020 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 Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

Recall notice