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U.S. Department of Health and Human Services

Class 2 Device Recall ProPlan CMF

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  Class 2 Device Recall ProPlan CMF see related information
Date Initiated by Firm November 08, 2013
Date Posting Updated December 26, 2013
Recall Status1 Terminated 3 on January 07, 2014
Recall Number Z-0578-2014
Recall Event ID 66935
Product ProPlan CMF Guide(s) Model(s)
REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only.

Used as surgical tools to transfer a pre-operative plan to surgery.
Code Information Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
Recalling Firm/
Materialise USA LLC
44650 Helm Ct
Plymouth MI 48170-6061
For Additional Information Contact Jenny Jones
Manufacturer Reason
for Recall
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
FDA Determined
Cause 2
Labeling Change Control
Action Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.
Quantity in Commerce 1
Distribution Distributed in Canada.

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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.