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

FDA Recall #Z-1569-2022 — Class II — July 13, 2022

Recall #Z-1569-2022 Date: July 13, 2022 Classification: Class II Status: Completed

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

Recalling Firm

Materialise USA LLC — Plymouth, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 unit

Distribution

US Nationwide distribution in the state of MD.

Code Information

Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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