Arthrex® AR-603-A608Recalls & reported problems
Arthrex, Inc. · IBAL TKA TIB BRNG TRL CR + SZ 6,8MM · 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 00888867112773), received between Nov 7, 2023 and May 26, 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
- Crack1
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 26, 2024Crack; Crack
ON 12/8/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-603-A608 TIBIAL BEARING CRACKED. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2021. SURGEON USED THICKER DEVICE TO COMPLETE CASE WITHOUT FURTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 19398865 ↗MalfunctionNov 7, 2023Break; Break
ON 10/13/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-06057425 THAT AN AR-603-A608 IBALANCE TKA TIB BRNG TRIAL CR + SZ 6,8MM BROKE WHEN REMOVING THE TRIAL FROM THE KNEE. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED BY OPENING A NEW TRAY. THE DELAY IN THE CASE IS UNKNOWN AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON 10/13/2023, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18085913 ↗
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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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