Arthrex® AR-602-21Recalls & reported problems
Arthrex, Inc. · iBALANCE PFJ, BLADE STABILIZER SIZE 2 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867038189), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Positioning Failure; Positioning Failure
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-602-21 IBALANCE PFJ, BLADE STABILIZER WOULD NOT LOCK INTO THE GUIDE. THE BLADE STABILIZERS' WASHER BELOW THE BALL BEARING SEEMED RAISED, PROHIBITING THE INSTRUMENT FROM ENGAGING WITH THE GUIDE. THIS WAS DISCOVERED DURING THE FEMORAL FINISHING STEP OF THE PFJ ARTHROPLASTY PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643950 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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