TOTAL MANDIBULAR SYSTEM 24-2115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036060824), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K062842); 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.

• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER ATTACHING THE DRILL TO THE HANDPIECE, THE DRILL FRACTURED WHILE CHECKING THE ROTATION. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362292 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062842. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2010 · Nov 6, 2009 · Terminated
  Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218