Arthrex® AR-601-TBE9Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEA-RING TRL SZ 5 || 9MM · 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 00888867037694), received between Jan 4, 2022 and Jun 4, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Naturally Worn1
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.
MalfunctionJun 4, 2024Naturally Worn; Naturally Worn
ON 2/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-601-TBE9 IBALANCE TIBIAL BEARING TRIAL IS WORN. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 2/3/2023: THIS WAS DISCOVERED DURING A UNI KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023. THE BEARING TRIAL WAS USED AS PART OF THE PROCEDURE AND AT THAT TIME IT WAS DISCOVERED THAT IT WAS TOO WORN.
Patient problems: Insufficient Information
MAUDE report 19459328 ↗MalfunctionJan 4, 2022Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-601-TBE9 TIBIAL INSERT TRIAL BROKE UPON REMOVAL FROM THE KNEE. THIS WAS DISCOVERED DURING AN UKA PROCEDURE ON (B)(6) 2021. THE BROKEN FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13154403 ↗
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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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