Materialise N.V.: Medical Device Recall in 2020 - (Recall #: Z-1485-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 3, 2020

Date Posted: March 25, 2020

Recall Number: Z-1485-2020

Event ID: 85080

Reason for Recall:

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

Status: Terminated

Product Quantity: 1

Code Information:

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

Distribution Pattern:

US: NY. OUS: Italy

Voluntary or Mandated:

Voluntary: Firm initiated