FDA Recall
Terminated
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. .
Recall: Z-0578-2014
·
Initiated November 8, 2013
Recall
- Recall Number
- Z-0578-2014
- Event Number
- 66935
- Firm
- Materialise USA LLC
- FEI Number
- 3005718816
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- November 8, 2013
- Posted
- December 26, 2013
- Terminated
- January 7, 2014
- Address
- 44650 Helm Ct, Plymouth, MI, 48170-6061
Description
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. .
Reason
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Action
Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.
Distribution
Distributed in Canada.
Quantity
1