Home / Recalls / Materialise N.V. / Z-1485-2020

Z-1485-2020 Class II Terminated

Recalled by Materialise N.V. — Heverlee

FDA device recall Z-1485-2020 was initiated by Materialise N.V. on Feb 3, 2020 and is designated Class II. Reason for recall: Custom surgical kits contain a plate different than indicated by the package labeling. The recall status is terminated (terminated Mar 20, 2020). Affected quantity: 1.

Recall details

Product Type: Devices
Report Date: Mar 25, 2020
Initiation Date: Feb 3, 2020
Termination Date: Mar 20, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Product description

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

Reason for recall

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

Distribution pattern

US: NY. OUS: Italy

Code information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1485-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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