Medical device recalls Moderate risk

Materialise USA LLC recalls ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Recall date
July 13, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1569-2022
FDA classification
Class II
Brand / firm
Materialise USA LLC
Sold / distributed
US Nationwide distribution in the state of MD.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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