Recall Z-1485-2020— Materialise N.V.

Name: FDA recall Z-1485-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-03

Class II · Terminated

Class II FDA medical device recall by Materialise N.V., initiated 2020-02-03, terminated 2020-03-20. It names one FDA 510(k) clearance: K170272. Product: TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013. Reason: Custom surgical kits contain a plate different than indicated by the package labeling..

Recalling firm: Materialise N.V.
Classification: Class II
Status: Terminated
Initiated: 2020-02-03
Terminated: 2020-03-20
Firm location: Heverlee, Belgium

510(k) clearances named in this recall

1 on FDA's record

K170272 — TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV·cleared 2017-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.