Materialise Recalls TRUMATCH Orthognathics Genioplasty Surgical Kit Due to Labeling Error
Materialise N.V. is recalling TRUMATCH Orthognathics Genioplasty Surgical Kits because the package labeling indicates a different plate than the one actually contained in the kit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Materialise N.V. is recalling one unit of the TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013. The recall is due to a labeling discrepancy where the package labeling indicates a different plate than the one actually contained in the kit.
The affected product is identified by Lot Number ME19-ZIK-VIK and UDI (01)05420060380136(10)ME19ZIKVIK. The distribution pattern for this recall includes New York, USA, and Italy.
Consumers and healthcare providers should check their inventory for this specific catalog number and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the point of purchase.
The recalled product
- Product
- TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
- Manufacturer
- Materialise N.V.
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: ME19-ZIK-VIK
- UDI: (01)05420060380136(10)ME19ZIKVIK
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Materialise N.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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