Arthrex® AR-603-A908Recalls & reported problems
Arthrex, Inc. · iBAL TKA TIBIAL BEARNG CR + SZ 9, 8MM · 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 00888867188129), received between Feb 14, 2022 and Feb 14, 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
- Crack1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2022Break; Crack
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-603-A908 TIBIAL BEARING BROKE WHILE ATTEMPTING TO INSERT THE DEVICE. WHILE IMPACTING THE DEVICE CRACKED CLEANLY INTO TWO PIECES. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE BEARING WAS REPLACED AND THE CASE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 13528688 ↗
Other TEMPLATE devices
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- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
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- 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.
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