ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Interme
FDA device recall Z-0577-2014 · posted 2013-12-26 · Terminated
Recall details
- Recalling firm
- Materialise USA LLC
- Reason for recall
- Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
- Action taken
- Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Quantity affected
- 1
- Distribution
- Distributed in Canada.
- Date initiated
- 2013-11-08
- Date posted
- 2013-12-26
- Date terminated
- 2014-01-07
- Location
- Plymouth, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.