Arthrex® AR-613-43Recalls & reported problems
Arthrex, Inc. · IBALANCE TKA, OFFSET TOWER · 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 00888867116443), received between Oct 5, 2021 and Nov 2, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Component Missing1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2021Break
ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-613-43 IBALANCE HAS A PRONG THAT BROKE APART. THIS OCCURRED WHEN PERFORMING THE LIGAMENT BALANCING PORTION OF THE TKA. THE BONE QUALITY OF THE PATIENT WAS NORMAL. THE FRAGMENTS OF THE BROKEN DEVICE WERE FULLY RETRIEVED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 10/14/2021: A TKA WAS BEING PERFORMED. THE DEVICE SNAPPED DURING LIGAMENT BALANCING. NO ATTACHMENT WAS BEING USED. CASE COMPLETED USING A BACK UP PIECE.
Patient problems: Insufficient Information
MAUDE report 12737918 ↗MalfunctionOct 5, 2021Break; Component Missing
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-43 IBALANCE TKA OFFSET TOWER WAS MISSING A PIECE FROM THE TIP. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON 09/15/2021. ADDITIONAL INFORMATION 9/22/2021 ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-43 IBALANCE TKA OFFSET TOWER WAS MISSING A PIECE FROM THE TIP. PER THE SALES REP, HE DOES NOT HAVE THE PIECE THAT WAS BROKEN OFF AND IS NOT SURE WHEN IT WENT MISSING. THEY DID NOT NOTICE UNTIL AFTER THE CASE ON (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 12576927 ↗
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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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