ProPlan CMF Patient-Specific Guide — Class II medical device recall Z-2287-2023
Completed recall by Materialise N.V., reported 2023-08-09, distributed nationwide. Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
| Recall number | Z-2287-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise N.V., Heverlee, N/A, Belgium |
| Recall initiated | 2023-06-19 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 05420060351013 |
Product
ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
Reason for recall
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
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-2287-2023. 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.