FDA Device recall Z-0577-2014
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use On…
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use On… by Materialise Usa, citing patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0577-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Materialise Usa |
| Distribution | n/a |
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.
Identifiers
| code_info | Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0577-2014%22
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