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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85080

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 03, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Materialise N.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

Z-1484-2020
Recall number
Z-1484-2020
Initiated
February 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Materialise N.V.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Custom surgical kits contain a plate different than indicated by the package labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Number: MU20VAFVEK, UDI: (01)05420060380013(10)MU20VAFVEK

Distribution pattern

US: NY. OUS: Italy

device · product 2 of 2

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

Z-1485-2020
Recall number
Z-1485-2020
Initiated
February 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Materialise N.V.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Custom surgical kits contain a plate different than indicated by the package labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US: NY. OUS: Italy