HU-FRIEDY E303Recalls & reported problems
Hu-Friedy Mfg. CO., LLC · #303 Apexo Elevator · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889950009120), received between May 17, 2022 and Jul 10, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Break; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25779836 ↗MalfunctionMay 17, 2022Break; Break
HU-FRIEDY WAS NOTIFIED OF A COMPLAINT WHERE THE TIP OF A DENTAL ELEVATOR DETACHED IN A PATIENT'S MOUTH DURING A DENTAL PROCEDURE ON (B)(6) 2020. THE TIP OF THE DENTAL ELEVATOR WAS REMOVED FROM THE PATIENT'S JAW DURING A SUBSEQUENT PROCEDURE.
Patient problems: Pain
MAUDE report 14416714 ↗
Other ELEVATOR, SURGICAL, DENTAL devices
- N/A 09-0257Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL57 reports
- N/A 09-0252Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL49 reports
- N/A SP-2359Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL28 reports
- N/A 09-0313Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL17 reports
- N/A 09-0262Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL15 reports
- N/A 09-0386Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL9 reports
- N/A 09-0258Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL8 reports
- N/A 09-0259Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.