Recall Z-1569-2022— Materialise USA LLC

Name: FDA recall Z-1569-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-13

Class II · Completed

Class II FDA medical device recall by Materialise USA LLC, initiated 2022-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208. Reason: MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK.

Recalling firm: Materialise USA LLC
Classification: Class II
Status: Completed
Initiated: 2022-07-13
Firm location: Plymouth, MI, United States

Product description

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Reason for recall

MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

Data sourced from openFDA. This site is unofficial and independent of the FDA.