Date Initiated by Firm |
November 08, 2013 |
Date Posted |
December 26, 2013 |
Recall Status1 |
Terminated 3 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 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. |
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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.
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