Arthrex® AR-601-TBA8Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEA-RING TRL SZ 1 || 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 00888867037441), received between May 21, 2024 and Jun 8, 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 8, 2024Naturally Worn; Naturally Worn
ON 04/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBA8 IBAL BEARING IS WORN OUT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19494455 ↗MalfunctionMay 21, 2024Break; Break
ON 9/23/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBA8 TIBIAL BEARING TRIAL 8MM AND AR-601-TBA9 TIBIAL BEARING TRIAL 9MM BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19359788 ↗
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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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