FDA Device recall Z-1485-2020
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 by Materialise N V, citing custom surgical kits contain a plate different than indicated by the package labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1485-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-03 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Materialise N V |
| Distribution | NY |
Product
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Reason
Custom surgical kits contain a plate different than indicated by the package labeling.
Identifiers
| code_info | Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1485-2020%22
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