TruMatch SD980.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060380112), received between Feb 25, 2022 and Feb 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

2 other recalls 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2022Malposition of Device; Malposition of Device

  PATIENT HAS ASSYMETRY IN THE CHIN AREA.

  Patient problems: Physical Asymmetry

  MAUDE report 13597532 ↗

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-1485-2020 · Feb 3, 2020 · Terminated
  TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
• Z-1484-2020 · Feb 3, 2020 · Terminated
  TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001