• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ProPlan CMF

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ProPlan CMF see related information
Date Initiated by Firm November 08, 2013
Date Posting Updated 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.

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.
-
-