Z-0578-2014 Class II Terminated
FDA device recall Z-0578-2014 was initiated by Materialise USA LLC on November 8, 2013 and is designated Class II. Reason for recall: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. The recall status is terminated (terminated January 7, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2014
- Initiation Date
- November 8, 2013
- Termination Date
- January 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product 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 for Recall
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Distribution Pattern
Distributed in Canada.
Code Information
Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_2