Integra® Jarit® 460405Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780394174), received between Oct 25, 2022 and Oct 25, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2022Break; Break

  THIS IS 1 OF 3 REPORTS AND IS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00240, 3014334038-2022-00241. A FACILITY REPORTED HAVING ISSUES WITH THE CARBIDE BURS (DFG700L) BREAKING, IMMEDIATELY. IT WAS REPORTED THAT THIS EVENT OCCURRED DURING DENTAL EXTRACTION. PIECES FELL INTO THE SURGICAL SITE AND WAS REMOVED WITH THUMB FORCEPS. NOT ALL BROKEN PIECES WERE RECOVERED; HOWEVER, NO PIECES WERE LEFT INSIDE THE PATIENT. NO PATIENT INJURY OR SIGNIFICANT DELAY IN SURGERY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670797 ↗
• MalfunctionOct 25, 2022Break; Break

  THIS IS 3 OF 3 REPORTS AND IS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00239, 3014334038-2022-00240. A FACILITY REPORTED HAVING ISSUES WITH THE CARBIDE BURS (DFG700L) BREAKING, IMMEDIATELY. IT WAS REPORTED THAT THIS EVENT OCCURRED DURING DENTAL EXTRACTION. PIECES FELL INTO THE SURGICAL SITE AND WAS REMOVED WITH THUMB FORCEPS. NOT ALL BROKEN PIECES WERE RECOVERED; HOWEVER, NO PIECES WERE LEFT INSIDE THE PATIENT. NO PATIENT INJURY OR SIGNIFICANT DELAY IN SURGERY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670601 ↗