Materialise Recalls TRUMATCH Orthognathic Surgical Kit Due to Labeling Error
Materialise N.V. is recalling TRUMATCH Orthognathic surgical kits because the package labeling indicates a different plate than the one actually included.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text describes a labeling error without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
Materialise N.V. is recalling the TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001. The recall is due to a labeling discrepancy where the package indicates a specific plate, but the kit contains a different plate than indicated.
The affected product is identified by Lot Number MU20VAFVEK and UDI (01)05420060380013(10)MU20VAFVEK. Distribution was limited to New York, USA, and Italy. The source text does not specify the number of units recalled or the specific dates of distribution.
Healthcare providers and patients should verify the contents of the surgical kit against the package labeling before use. If a discrepancy is found, the product should not be used, and the recalling firm should be contacted for further instructions.
The recalled product
- Product
- TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
- 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: MU20VAFVEK
- UDI: (01)05420060380013(10)MU20VAFVEK
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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