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HU-FRIEDY E301Recalls & reported problems

Hu-Friedy Mfg. CO., LLC · #301 Apexo Elevator · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889950009083), received between May 11, 2023 and May 11, 2023 — classified as 1 malfunction.

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

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

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionMay 11, 2023Break; Break

    THE USER FACILITY REPORTED THAT DURING TWO SEPARATE DENTAL PATIENT PROCEDURES THE TIP OF A 301 APEXO ELEVATOR BROKE OFF IN THE PATIENT'S MOUTH. FOR THE FIRST PATIENT, THE TIP WENT INTO THE SINUS AND REQUIRED AN ADDITIONAL PROCEDURE TO RETRIEVE THE BROKEN PART. THE TIP WAS IMMEDIATELY RETRIEVED FROM THE SECOND PATIENT'S MOUTH. ALL COMPONENTS WERE SUCCESSFULLY RETRIEVED IN BOTH CASES.

    Patient problems: Foreign Body In Patient

    MAUDE report 16911343 ↗

Other ELEVATOR, SURGICAL, DENTAL devices

All ELEVATOR, SURGICAL, DENTAL devices →

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