Tornier Flex MWF602SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386977121), received between Nov 4, 2025 and Nov 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Residue After Decontamination” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT UPON INSPECTION OF THE INSTRUMENT TRAY AT THE WAREHOUSE, BLOOD AND/OR BONE RESIDUE WAS FOUND INSIDE AN INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584586 ↗
• MalfunctionNov 17, 2025Residue After Decontamination; Residue After Decontamination

  UPON INSPECTION OF TRAY AT WAREHOUSE, BLOOD/BONE FOUND INSIDE OF INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576733 ↗
• MalfunctionNov 4, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT, UPON INSPECTION AT THE WAREHOUSE, BLOOD RESIDUE WAS OBSERVED INSIDE THE INSTRUMENTS ASSOCIATED WITH THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464482 ↗