Arthrex® AR-601-TBE8Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEA-RING TRL SZ 5 || 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 00888867037687), received between Feb 3, 2021 and Feb 24, 2025 — 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.
Reports received per month
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.
MalfunctionFeb 24, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-601-TBE8 IBALANCE¿ UKA BROKE. THIS OCCURRED DURING A KNEE ARTHROSCOPY WHILE REMOVING. THE DEVICE WAS REMOVED AND THE PATIENT IS OKAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446687 ↗MalfunctionFeb 3, 2021Break
IT WAS REPORTED DURING A PARTIAL KNEE REPLACEMENT A SMOOTH GUIDE PIN COLD WELDED INTO THE AR-611-TRLM LEFT TIBIAL CUTTING GUIDE. THE SURGEON WAS ABLE TO COMPLETE THE CUT WITH A SINGLE PIN IN PLACE AND HOLDING THE GUIDE IN PLACE. DURING THE PROCEDURE A SMALL PIECE OF THE AR-601-TBE8 8MM TRIAL BROKE OFF. THE REP REPORTED THE PIECE WAS EASILY RETRIEVED, BUT THROWN OUT. ADDITIONAL INFORMATION RECEIVED ON 1/25/2021: THE TRIAL POLY BROKE WHILE INSERTING IT FOR TRIAL. IT BROKE INTO TWO DISTINCT PIECES WHILE TRIALING IT IN THE KNEE. THE SMALLER PIECE THAT BROKE OFF FELL ONTO THE OR TABLE AND WAS DISCARDED AFTER ASSESSING THAT THE TWO PIECES ACCOUNTED FOR THE ENTIRE TRIAL COMPONENT AND THERE WAS NO MISSING PIECE. THERE WERE NO UNPLANNED INCISIONS. THE CASE WAS COMPLETED WITHOUT DIFFICULTY, AS THE REMAINING TRIAL COMPONENT WAS ADEQUATE TO TRIAL AND THE DECISION FOR THE FINAL IMPLANTABLE COMPONENT WAS MADE.
Patient problems: Insufficient Information
MAUDE report 11275721 ↗
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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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