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U.S. Department of Health and Human Services

Class 2 Device Recall Materialise

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  Class 2 Device Recall Materialise see related information
Date Initiated by Firm July 13, 2022
Create Date August 24, 2022
Recall Status1 Completed
Recall Number Z-1569-2022
Recall Event ID 90704
Product Classification Template - Product Code HWT
Product ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear
Identification number SD900.208
Code Information Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ
Recalling Firm/
Manufacturer		 Materialise USA LLC
44650 Helm Ct
Plymouth MI 48170-6061
For Additional Information Contact SAME
734-259-6669
Manufacturer 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
FDA Determined
Cause 2		 Employee error
Action Materialise USA LLC notified field representative via telephone on 13 July 2022 requesting the case to be returned. A replacement case was sent on 14 July 2022. Materialise picked up/received MU22-INQ-DUQ case with anatomical model MU22-NOF-SAK on 22 July 2022. This recall can be terminated as all distributed product (one case) has been returned to Materialise. No additional product remains in the field.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of MD.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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