Recall Z-0577-2014— Materialise USA LLC
Class II · Terminated
Class II FDA medical device recall by Materialise USA LLC, initiated 2013-11-08, terminated 2014-01-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information..
- Recalling firm
- Materialise USA LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-08
- Terminated
- 2014-01-07
- Firm location
- Plymouth, MI, United States
Product description
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.
Reason for recall
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Data sourced from openFDA. This site is unofficial and independent of the FDA.