Arthrex® AR-603-A508Recalls & reported problems
Arthrex, Inc. · IBAL TKA TIB BRNG TRL CR + 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 00888867112698), received between May 20, 2024 and Jun 12, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2024Crack; Crack
IT WAS REPORTED THAT THE TIBIAL BEARING TRIALS ARE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519868 ↗MalfunctionMay 20, 2024Crack; Crack
ON 4/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-603-A508 IBAL TKA TIB BRNG TRL CRACKED IN HALF UPON REMOVAL OF THE TRIAL DURING A CASE. NO OTHER PARTS WERE NECESSARY AS THE TRIAL PORTION OF THE CASE WAS COMPLETED, AND NO SECONDARY SURGERY WAS NEEDED. NO ADDITIONAL TIME WAS ADDED TO THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 4/25/2024: THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2024. THE DEVICE BROKE INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED WITHOUT ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353065 ↗
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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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