Arthrex® AR-2285-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867026650), received between Mar 18, 2024 and Mar 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Fitting Problem; Fitting Problem

  ON 03/01/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-2285-09 GRAFT KNIFE BLADES WILL NOT FIT INTO THE HANDLE. THERE IS AN UNUSUAL AMOUNT OF FORCE NEEDED TO SEAT BLADES. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923663 ↗
• MalfunctionMar 18, 2024Fitting Problem; Fitting Problem

  ON 03/01/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-2285-09 GRAFT KNIFE BLADES WILL NOT FIT INTO THE HANDLE. THERE IS AN UNUSUAL AMOUNT OF FORCE NEEDED TO SEAT BLADES. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923650 ↗