Arthrex® AR-601-TBC9Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEA-RING TRL SZ 3 || 9MM · Class 1
Data updated Oct 18, 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 00888867037571), received between Mar 28, 2022 and Mar 28, 2022 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
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.
MalfunctionMar 28, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBC9 IBALANCE¿ UKA, TIBIAL BEARING TRIAL, SIZE 3, 9 MM BROKE DURING A CASE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A PRIMARY UNI KNEE PROCEDURE ON (B)(6) 2022. THE INSTRUMENT WAS NOT USED WITH POWER. THE DEVICE BROKE AS THEY WERE TRYING TO GET IT OUT OF THE PATIENT. IT WAS REMOVED IN TWO PIECES, IT GOT STUCK AND WHEN REMOVING IT, THE PIECE POPPED OFF AND WENT FLYING TO THE FLOOR. THEY WERE DONE TRIALING WHEN THE DEVICE BROKE, SO THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13929217 ↗
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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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