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.
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, 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Materialise N.V.
See all →- HighProPlan CMF Mandible Surgical Guides Recall for Wrong Version
FDA (Devices) · 2023-08-09
- HighMRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient
FDA (Devices) · 2023-07-26
- LowMatch Point System surgical instrument recalled due to incorrect procedure side labeling
FDA (Devices) · 2020-09-02
- ModerateMaterialise Recalls TRUMATCH Orthognathic Surgical Kit Due to Labeling Error
FDA (Devices) · 2020-03-25
- HighMaterialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies
FDA (Devices) · 2015-11-04
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighMaterialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
FDA (Devices) · 2014-01-01
- HighMaterialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error
FDA (Devices) · 2016-06-15
- ModerateDT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling
FDA (Devices) · 2018-11-14
- ModerateSynthes Orthopedic Guide Blocks Recalled for Incorrect Labeling
FDA (Devices) · 2014-07-30
- LowSynthes SynMesh Cage System Recalled for Incorrect Statutory Labeling
FDA (Devices) · 2020-11-11
- LowSynthes SynMesh Cage System Recalled for Incorrect Labeling
FDA (Devices) · 2020-11-11