Arthrex® AR-9126RCRecalls & reported problems
Arthrex, Inc. · UNIVERSAL GLENOID CORRECTION REAMER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00888867057616), received between Apr 3, 2024 and Apr 24, 2024 — classified as 2 malfunctions.
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. 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
- Break1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE SURGEON WAS HAVING TROUBLE WITH THE NEW NITINOL GUIDE PINS FITTING THROUGH THE AR-9126RP AND AR-9126RC POST REAMERS. REPLACING ONE OF THE PRIMARIES RESOLVED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171878 ↗MalfunctionApr 3, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9126RC CORRECTION REAMER BROKE, AND AN AR-9165CDG ASSEMBLY, AN AR-9545-T15-01 DRIVER SHAFT, AN AR-9545-T15-02 DRIVER SHAFT, AND AN AR-9545-T15-03 DRIVER SHAFT ARE BENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO PIECE BROKE OFF INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19034847 ↗
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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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