FDA recall Z-1484-2020
Materialise N.V. · Class II · device
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.
Distribution
US: NY. OUS: Italy
Key facts
- Status
- Terminated
- Initiation date
- 2020-02-03
- Report date
- 2020-03-25
- Termination date
- 2020-03-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Heverlee, Belgium
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2020