Z-1485-2020Class II

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

Name: Z-1485-2020 TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Creator: Materialise N.V.
Published: 2020-02-03
License: https://open.fda.gov/license/

Materialise N.V. / initiated 2020-02-03 / Terminated / root cause: manufacturing process

FDA source

Materialise N.V. began a recall of TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 on 2020-02-03. FDA classified it as Class II and gives the reason as "Custom surgical kits contain a plate different than indicated by the package labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1485-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-03
Posted: 2020-04-06
Terminated: 2020-03-20
Recalling firm: Materialise N.V.
Product: TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Product code: JEY Plate, Bone
Reason for recall: Custom surgical kits contain a plate different than indicated by the package labeling.
Root cause tag: manufacturing process
FDA root cause: Employee error
Quantity in commerce: 1
Distribution: US: NY. OUS: Italy
Product codes and lots: Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1485-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1484-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1485-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

Product code JEY

K170272Class IITruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV / cleared 2017-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)