Arthrex® AR-623-T308Recalls & reported problems
Arthrex, Inc. · IBAL TKA,TIB BEARING TRL SZ 3, 8MM · Class 1
Data updated Oct 18, 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 00888867215061), received between Mar 30, 2021 and May 18, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2021Break
IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE SURGEON WAS USING THE HOOK PROBE TO REMOVE THE AR-623-T308, TRAIL AND THE DEVICE BROKE. ALL PIECES WERE REMOVED AND THE CASE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 11842692 ↗MalfunctionMar 30, 2021Break
IT WAS REPORTED DURING A TKA PROCEDURE THE AR-623-T308 TRIAL BROKE WHILE CYCLING THE KNEE. THE REP REPORTED ALL PIECES WERE RECOVERED AND THE CASE WAS COMPLETED. THE PATIENT WAS NOT HARMED. SEE ATTACHED IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11591758 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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