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U.S. Department of Health and Human Services

Class 2 Device Recall ProPlan CMF

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 Class 2 Recall
ProPlan CMF
see related information
Date Posted December 26, 2013
Recall Status1 Terminated 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/
Manufacturer
Materialise USA LLC
44650 Helm Ct
Plymouth, Michigan 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 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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