Arthrex® AR-9501HC-1Recalls & reported problems
Arthrex, Inc. · Univers Revers Humeral Case(1of2) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867184091), received between Apr 10, 2024 and Jun 17, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Flaked” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Flaked2
- Corroded1
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 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 19548145 ↗MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT AR-9501HC-1 IS BENT AND MISSING THE TRAY HANDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521569 ↗MalfunctionMay 21, 2024Flaked; Flaked
IT WAS REPORTED THAT THE CASE HAS PLASTIC THAT IS BROKEN AND FLAKING.
Patient problems: Insufficient Information
MAUDE report 19357628 ↗MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE AR-9501HC-1 IS RUSTING AND PART OF THE TRAY IS COMING APART. SEE ATTACHED IMAGES.
Patient problems: Insufficient Information
MAUDE report 19165080 ↗MalfunctionApr 10, 2024Corroded; Corroded
IT WAS REPORTED THAT RUST WAS FOUND IN THE FOLLOWING TRAYS AFTER STERILE PROCESSING; AR-9501HC-1 AND AR-9501HC-2.
Patient problems: Insufficient Information
MAUDE report 19081625 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
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- 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
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
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- HarmonyAIR LAS0042Steris Corporation · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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