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TruMatch SD980.013Recalls & reported problems

Materialise NV · TTRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K170272); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 3, 2020Terminated

    Custom surgical kits contain a plate different than indicated by the package labeling.

    Z-1485-2020 · Root cause: Employee error · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170272. One submission often covers many models, so check the product and lot details in each record.

  • Z-1484-2020 · Feb 3, 2020 · Terminated
    TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

Other Plate, Bone devices

All Plate, Bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.