Tornier Flex MWF601SRecalls & reported problems
Tornier · Standard Stem+ Compactor · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386977107), received between Nov 17, 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.
Reports received per month
Most reported problems
Device problems
- Residue After Decontamination3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
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 23584413 ↗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 23576248 ↗MalfunctionNov 17, 2025Residue After Decontamination; Residue After Decontamination
UPON INSPECTION OF TRAY AT WAREHOUSE, BLOOD/BONE FOUND INSIDE OF INSTRUMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23575244 ↗
Other INSTRUMENT, COMPRESSION devices
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- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.