Materialise N.V. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 5.

Medical DeviceAug 9, 2023

Materialise N.V ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to recall — FDA Z-2287-2023

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Class IIFDA: CompletedMaterialise N.V.

Medical DeviceJul 26, 2023

Materialise N.V MRI Biomet Pin Guide for Total Knee Arthroplasty recall — FDA Z-2213-2023

The wrong tibia guide was included intended for a different patient case.

Class IIFDA: CompletedMaterialise N.V.

Medical DeviceSep 2, 2020

Materialise N.V Match Point System The Match Point System is intended to by uses as a recall — FDA Z-2886-2020

The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

Class IIFDA: TerminatedMaterialise N.V.

Medical DeviceNov 4, 2015

Materialise N.V Signature Patient-Specific Surgical Guides recall — FDA Z-0162-2016

Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

Class IIFDA: TerminatedMaterialise N.V.

Medical DeviceMar 25, 2015

Materialise N.V Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature recall — FDA Z-1287-2015

Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation…

Class IIFDA: TerminatedMaterialise N.V.

Understanding this recall history

This page summarizes recall records in which the official source identifies Materialise N.V. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.