Device product
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Z-1485-2020
Product summary
- Firm
- Materialise N.V.
- Event
- Event 85080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1485-2020
Official wording
Reason: Custom surgical kits contain a plate different than indicated by the package labeling.
Code information: Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK
Distribution pattern: US: NY. OUS: Italy
Derived failure modes
-
Unknown
Custom surgical kits contain a plate different than indicated by the package labeling.