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. .
This recall has been terminated (originally issued December 26, 2013).
- Company
- Materialise Usa Llc
- Recall Initiated
- November 8, 2013
- Posted
- December 26, 2013
- Terminated
- January 7, 2014
- Recall Number
- Z-0578-2014
- Quantity
- 1
- Firm Location
- Plymouth, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Distribution
Distributed in Canada.
Lot / Code Info
Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
Root Cause
Labeling Change Control
Action Taken
Customer/ ordering physician was made aware of the issue11/08/2013. Revised accurate case report was immediately provided.
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