TRUMATCH Orthognathic — Class II medical device recall Z-1484-2020
Terminated recall by Materialise N.V., reported 2020-03-25, distributed in NY. Custom surgical kits contain a plate different than indicated by the package labeling.
| Recall number | Z-1484-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise N.V., Heverlee, Belgium |
| Recall initiated | 2020-02-03 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2020-03-20 |
| Distributed | NY |
| Countries outside the US | IT |
| Quantity | 1 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05420060380013 |
| Lot numbers | MU20VAFVEK |
| Model numbers | SD980.001 |
Product
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Reason for recall
Custom surgical kits contain a plate different than indicated by the package labeling.
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-1484-2020. 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.