Materialise N.V.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2287-2023Class IIProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone June 19, 2023
Z-2213-2023Class IIMRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)--April 26, 2023
Z-2886-2020Class IIMatch Point System The Match Point System is intended to by uses as a surgical instrument to assiJuly 17, 2020
Z-1484-2020Class IITRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001February 3, 2020
Z-1485-2020Class IITRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013February 3, 2020
Z-0162-2016Class IISignature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgSeptember 23, 2015
Z-1287-2015Class IISignature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides arFebruary 4, 2015