Materialise USA LLC
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. .
| Date | Dec 26, 2013 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. |
| Root cause | Labeling Change Control |
| Action | Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided. |
| Quantity | 1 |
| Distribution | Distributed in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.