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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. . Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2 Class II Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. 1 Z-0578-2014
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. Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01 Class II Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. 1 Z-0577-2014
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