Arthrex® AR-601-TBB8Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEA-RING TRL SZ 2 || 8MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867037502), received between Jan 3, 2023 and Mar 17, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2025Break; Break
ON 02/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-601-TBB8 IBALANCE UKA TIBIAL BEARING TRIAL BROKE DURING TRIALING WITH THE CORNER PIECE OF THE PLASTIC SHEARED OFF AND WAS SUCCESSFULLY REMOVED. NO PIECES BROKE OFF INSIDE THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A UKA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/07/2025: THE CASE WAS COMPLETED USING A BACK UP TRAY. ANOTHER AR-601-TBB8 WAS USED. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA. NO ADVERSE EFFECTS ON THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620260 ↗MalfunctionJun 10, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED ON 01/23/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBB8 TIBIAL BEARING IS CHIPPED. CASE INVOLVEMENT, NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED ON 01/25/2023. CONFIRMED VIA EMAIL, DEVICE DID NOT CHIP INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498432 ↗MalfunctionJan 3, 2023Break
IT WAS REPORTED ON 12/13/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBB8 TIBIAL BEARING CRACKED OFF. CASE INVOLVEMENT, DEVICE BROKE DURING USE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16086781 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page