Arthrex® AR-601-TBD8Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEA-RING TRL SZ 4 || 8MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867037625), received between Jul 20, 2021 and Jun 24, 2024 — classified as 6 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2024Crack; Crack
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-601-TBD8 IBALANCE¿ UKA CRACKED AND A SMALL PIECE BROKE OFF. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19595621 ↗MalfunctionJan 25, 2024Crack; Crack
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT DURING A CASE, A TIBIAL BEARING TRIAL, AR-601-TBD8, CRACKED. THE TRIAL WAS REPLACED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18579486 ↗MalfunctionMay 1, 2023Break; Break
ON 04/05/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBD8 TIBIAL BEARING TRIAL BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION IS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16846008 ↗MalfunctionFeb 16, 2023Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-601-TBD8 TIBIAL BEARING TRIAL IS DAMAGED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16387074 ↗MalfunctionOct 12, 2021Break
ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-601-TBD8 TIBIAL BEARING TRIAL WAS BROKEN DURING INSERTION. THIS OCCURRED DURING A TOTAL SHOULDER PROCEDURE. ALL WAS RETRIEVED. NO HARM TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 12616725 ↗MalfunctionJul 20, 2021Break
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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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