Device product
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. .
Z-0578-2014
Product summary
- Event
- Event 66935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0578-2014
Official wording
Reason: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Code information: Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2
Distribution pattern: Distributed in Canada.
Derived failure modes
-
Unknown
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.