CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report

Trumatch Orthognathics - Genioplasty Surgical Kit, Add recalled

Materialise N.V is recalling Trumatch Orthognathics - Genioplasty Surgical Kit, Add-on, distributed in New York. The recall was initiated on 3 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1485-2020
FDA event ID: 85080
Recalling firm: Materialise N.V, Heverlee
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2020
FDA classified: 13 Mar 2020
Reported: 25 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

3 Feb 2020	Recall initiated by company
13 Mar 2020	Classified by FDA	+39 days
25 Mar 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Custom surgical kits contain a plate different than indicated by the package labeling.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

Where it was distributed

US: NY. OUS: Italy

New York

Questions about this recall

Why was it recalled?

Custom surgical kits contain a plate different than indicated by the package labeling.

Which lots are affected?

Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK

Where was it sold?

US: NY. OUS: Italy

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 85080

This product is part of a recall event; the main page for the event is Trumatch Orthognathic - Full Bimaxillary Surgical Kit recalled.

Reported	Class	Recall	Company	Reason	Where
25 Mar 2020	CLASS II	Trumatch Orthognathic - Full Bimaxillary Surgical Kit recalled	Materialise N.V	Packaging Defects	NY

More recalls from Materialise N.V

All 7

Reported	Class	Recall	Company	Reason	Where
9 Aug 2023Device	CLASS II	ProPlan CMF Patient-Specific Guide, Mandible guides recalled	Materialise N.V	Other	Nationwide
26 Jul 2023Device	CLASS II	MRI Biomet Pin Guide for Total Knee Arthroplasty recalled	Materialise N.V	Other	N/A
2 Sep 2020Device	CLASS II	Match Point System The Match Point System is intended recalled	Materialise N.V	Nitrosamine Impurity	Nationwide
25 Mar 2020Device	CLASS II	Trumatch Orthognathic - Full Bimaxillary Surgical Kit recalled	Materialise N.V	Packaging Defects	NY
4 Nov 2015Device	CLASS II	Signature Patient-Specific Surgical Guides recalled by Materialise N.V	Materialise N.V	Labeling Errors	ID, MI, TX

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All 3,809

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