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Terminated

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

FDA Recall Z-1485-2020 · Posted None

Recalling FirmMaterialise N.V.
Recall StatusTerminated
Product CodeJEY
Date Initiated2020-02-03
Date Terminated2020-03-20
Product Quantity1

Reason for Recall

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

Root Cause

Employee error

Distribution Pattern

US: NY. OUS: Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017-08-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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