TruMatch recallZ-1484-2020 · Materialise N.V. · initiated Feb 3, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Materialise N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Custom surgical kits contain a plate different than indicated by the package labeling.
FDA root cause category: Employee error
Recall details
- Recall number
- Z-1484-2020
- Status
- Terminated
- Initiated by the company
- Feb 3, 2020
- Recalling firm
- Materialise N.V.
- Quantity
- 1
- Product code
- JEY
- FDA submissions
- K170272
- Distribution
- US: NY. OUS: Italy
Product description
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Code information (models, lots, serial numbers)
Lot Number: MU20VAFVEK, UDI: (01)05420060380013(10)MU20VAFVEK
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
Product lines
Other devices under the same FDA submission
10 devices cleared under K170272 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
- TruMatch SD980.014Materialise NV · Plate, Bone20 reports
- TruMatch SD980.020Materialise NV · Plate, Bone9 reports
- TruMatch SD980.021Materialise NV · Plate, Bone5 reports
- TruMatch SD980.003Materialise NV · Plate, Bone4 reports
- TruMatch SD980.017Materialise NV · Plate, Bone4 reports
- TruMatch SD980.005Materialise NV · Plate, Bone3 reports
- TruMatch SD980.011Materialise NV · Plate, Bone1 report
- TruMatch SD980.113Materialise NV · Plate, Bone1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 85080).
- Z-1485-2020 · TerminatedTRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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