TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit recall: Labeling Error
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Why was TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit recalled?
Custom surgical kits contain a plate different than indicated by the package labeling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: MU20VAFVEK, UDI: (01)05420060380013(10)MU20VAFVEK
- Product
- TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
- Recalling firm
- Materialise N.V.
- Quantity
- 1
- Distribution
- US: NY. OUS: Italy
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)