ATTUNE 2504-40-403Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295438014), received between Apr 1, 2019 and Sep 29, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Corroded” (6 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE HAS RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503905 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001475 ↗
• MalfunctionAug 20, 2019Corroded; Corroded

  THERE IS RUST ON THE BLACK CLIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912759 ↗
• MalfunctionAug 20, 2019Corroded; Corroded

  THERE IS RUST ON THE LASER MARKING. ALSO ON THE BLACK HANDLE, THERE IS RUST DEBRIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912641 ↗
• MalfunctionJul 8, 2019Corroded; Corroded

  BEFORE USE ON PATIENT; INSTRUMENTS ARE RUSTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8768806 ↗
• MalfunctionApr 1, 2019Corroded; Corroded

  "RUST" TYPE RESIDUE ON ATTUNE REVISION SIZE 3 NOTCH CUTTING BLOCK. REPORTED BY FREMANTLE CSSD DEPARTMENT WHO REFUSED TO STERILISE THE INSTRUMENT PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469038 ↗