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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description 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.
Recall Number Z-0577-2014
Classification Class II
Code Info Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01
Product Distributed Qty 1
Reason For Recall Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

Event Detail

Event Id 66935
Product Type Devices
Status Completed
Recalling Firm Materialise USA LLC
City Plymouth
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-08
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Distributed in Canada.