Class 2 Device Recall ProPlan CMF

• Date Initiated by Firm: November 08, 2013
• Date Posted: December 26, 2013
• Recall Status: Terminated on January 07, 2014
• Recall Number: Z-0577-2014
• Recall Event ID: 66935
• Product: ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate 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_01
• Recalling Firm/ Manufacturer: Materialise USA LLC; 44650 Helm Ct; Plymouth MI 48170-6061
• For Additional Information Contact: Jenny Jones; 734-662-5057
• Manufacturer Reason for Recall: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
• FDA Determined Cause: 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.