Arthrex® AR-9501HC-2Recalls & reported problems
Arthrex, Inc. · Univers Revers Humeral Case(2of2) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867184107), received between Jun 12, 2024 and Jun 19, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Corroded” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Corroded1
- Flaked1
- Material Separation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2024Flaked; Flaked
IT WAS REPORTED THAT THE FOLLOWING SETS ARE CHIPPED AND NEED TO BE REPLACED; AR-9217C, AR-9400C4, AR-9225C, AR-9226ABC, AR-9226UBC, AR-9226CC, AR-9501-HC2, AR-9501-HC1, AR-9615C-1, AR-9615C-2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566050 ↗MalfunctionJun 19, 2024Corroded; Corroded
IT WAS REPORTED THAT RUST WAS FOUND IN THE FOLLOWING TRAYS AFTER STERILE PROCESSING; AR-9501HC-1 AR-9501HC-2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19565896 ↗MalfunctionJun 14, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE AR-9501HC-2 IS RUSTING AND PART OF THE TRAY IS COMING APART.
Patient problems: Insufficient Information
MAUDE report 19537221 ↗MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT AR-9501HC-2 IS BENT AND MISSING THE TRAY HANDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521505 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
- Arthrex® AR-13995NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE430 reports
- Arthrex® AR-12990NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE197 reports
- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion Medical Products Corp SUT15830AMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page