Arthrex® AR-601-TBC8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867037564), received between May 10, 2021 and Apr 14, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break

  ON 24-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-601-TBC8 IBALANCE UKA, TIBIAL BEARING TRIAL, SIZE 3, 8 MM HAD BROKEN DURING A CASE. NO FURTHER DETAILS WERE PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 30-MAR-2026: IT WAS FURTHER REPORTED THE TRIAL BROKE DURING INSERTION FROM THE MALLET. THE TRIAL WAS NOT FULLY IN THE PATIENT AND ALL PIECES WERE RETRIEVED. THIS WAS DISCOVERED DURING A UNI KNEE PROCEDURE WITH NO CASE DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED. THE CASE WAS COMPLETED WITH THE CORRESPONDING IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 24876325 ↗
• MalfunctionJan 9, 2025Break; Break

  ON 12/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-601-TBC8 IBALANCE UKA, TIBIAL BEARING TRIAL, SIZE 3, 8 MM FELL APART WITH PIECES FOUND AND REMOVED WITH NO FURTHER INFORMATION PROVIDED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/17/2024: THIS WAS DISCOVERED DURING USE ON 12/09/2024. THE POLY BROKE, PULLING IT OUT OF THE PATIENT. BOTH PIECES WERE EASILY TAKEN OUT OF THE PATIENT. THIS ISSUE DID NOT DELAY THE CASE. THERE WAS NO ADVERSE REACTION TO THE CASE OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113201 ↗
• MalfunctionJul 11, 2024Material Fragmentation; Material Fragmentation

  ON 06/18/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-301-TBC8 IBAL UKA TIB BEA-RING TRL SZ 3 // 8MM HAD NORMAL WEAR AND TEAR WITH A CHIP. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721717 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023, BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBC8 TIBIAL BEARING PART BROKE OFF DURING UNI KNEE SURGERY. CASE INVOLVEMENT, THE DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751606 ↗
• MalfunctionMay 10, 2021Break

  IT WAS REPORTED THAT THE AR-601-TBC8 TIBIAL TRIAL BROKE WHEN REMOVING. THE REP REPORTED THERE WERE NO DELAYS CAUSED AND ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 11798861 ↗