ProPlan CMF Guide — Class II medical device recall Z-0577-2014
Terminated recall by Materialise USA LLC, reported 2014-01-01. Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical
| Recall number | Z-0577-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise USA LLC, Plymouth, MI, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2013-12-26 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-01-07 |
| Countries outside the US | CA |
| Quantity | 1 |
| Model numbers | D900.008 |
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 for recall
Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0577-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.