FDAFDA · Food and drugs·Recall number Z-1484-2020
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Published March 25, 2020 · Recall initiated: February 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Custom surgical kits contain a plate different than indicated by the package labeling.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Materialise N.V.
- Distributor
- US: NY. OUS: Italy
- Lot
- Lot Number: MU20VAFVEK, UDI: (01)05420060380013(10)MU20VAFVEK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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