Arthrex® AR-601-TBP4Recalls & reported problems
Arthrex, Inc. · iBALANCE UKA, BASE PLATE TRIAL, SIZE 4 · 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 00888867037809), received between Jun 7, 2024 and Jun 7, 2024 — 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.
Reports received per month
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.
MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE METAL TIP ON THE AR-9215-1-02 GLENOID DRILL GUIDE HANDLE HAS BEEN COMPROMISED. AFTER INSERTION OF THE AR-601-TBP4 POLY TRIAL WITH THE HANDLE, THE METAL CONNECTION CRACKED CLEANLY OFF INTO THE TRIAL WHERE IT IS UNABLE TO BE REMOVED. THE REP REPORTED NO PIECES WERE LOST, AND BOTH PIECES WILL BE RETURNED. AS THE TRIAL HAD ALREADY BEEN PLACED, THERE WAS NO FURTHER NEED OF THE BASE PLATE TRIAL OR AN ALTERNATIVE INSTRUMENT. THERE WAS NO DELAY IN SURGERY, A SECOND SURGERY WILL NOT BE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488638 ↗
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- 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.
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