Recall Z-1484-2020 ยท JEY Plate, Bone
Materialise N.V.
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
| Date | Feb 3, 2020 |
| Status | Terminated |
| Reason | Custom surgical kits contain a plate different than indicated by the package labeling. |
| Root cause | Employee error |
| Quantity | 1 |
| Distribution | US: NY. OUS: Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170272 | TruMatch CMF Titanium 3D Printed Implant System Materialise NV, Aug 8, 2017 |