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Materialise USA Recalls
6 recalls on record · January 1, 2014 to August 31, 2022 · Medical Devices
Recalls by year
14
16
22
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 31, 2022Medical DevicesFDA
Materialise USA LLC recalls ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Hazard: MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK
June 15, 2016Medical DevicesFDA
Materialise USA LLC recalls Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Hazard: A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
December 3, 2014Medical DevicesFDA
Materialise USA LLC recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrume
Hazard: The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
January 15, 2014Medical DevicesFDA
Materialise USA LLC recalls REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-
Hazard: Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
January 1, 2014Medical DevicesFDA
Materialise USA LLC recalls ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Fina
Hazard: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
January 1, 2014Medical DevicesFDA
Materialise USA LLC recalls ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Inte
Hazard: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.