Materialise USA LLC

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1569-2022Class IIProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208July 13, 2022
Z-1941-2016Class IISignature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.May 3, 2016
Z-0418-2015Class IIZimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used asOctober 16, 2014
Z-0628-2014Class IIREF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MPNovember 26, 2013
Z-0577-2014Class IIProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide,November 8, 2013
Z-0578-2014Class IIProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide,November 8, 2013