ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Summary
The FDA issued a Class II for ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD90 by Materialise USA LLC. Reason: MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK.
Details
Source
Device Recall
External ID
Z-1569-2022
Action Date
2022-08-31
Status
Completed
Category
device
Product Description
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
Lot/Code Info: Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
Quantity Affected: 1 unit
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
Distribution
US Nationwide distribution in the state of MD.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-13
Company
Plymouth, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Materialise USA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Materialise USA LLC have FDA actions?
This is the only FDA action we have on record for Materialise USA LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1569-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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