Home / Brands / Materialise N.V
Materialise N.V Recalls
7 recalls on record · March 25, 2015 to August 9, 2023 · Medical Devices
Recalls by year
15
20
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 9, 2023Medical DevicesFDA
Materialise N.V. recalls ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgica
Hazard: Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
July 26, 2023Medical DevicesFDA
Materialise N.V. recalls MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev
Hazard: The wrong tibia guide was included intended for a different patient case.
September 2, 2020Medical DevicesFDA
Materialise N.V. recalls Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraopera
Hazard: 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.
March 25, 2020Medical DevicesFDA
Materialise N.V. recalls TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Hazard: Custom surgical kits contain a plate different than indicated by the package labeling.
March 25, 2020Medical DevicesFDA
Materialise N.V. recalls TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Hazard: Custom surgical kits contain a plate different than indicated by the package labeling.
November 4, 2015Medical DevicesFDA
Materialise N.V. recalls Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for t
Hazard: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
March 25, 2015Medical DevicesFDA
Materialise N.V. recalls Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be use
Hazard: 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 and use of traditional instrumentation.