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Tornier Flex MWF612SRecalls & reported problems

Tornier · Long Stem+ Compactor · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386977282), received between Feb 14, 2020 and Feb 14, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 14, 2020Material Fragmentation; Material Fragmentation

    TRAY SHEARED OFF INSIDE THE COMPACTOR FOR NO OBVIOUS REASON. BACKUP DEVICE USED. DELAY IN SURGERY THE TIME TO RETRIEVE ALTERNATIVE INSTRUMENTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9710851 ↗

Other INSTRUMENT, COMPRESSION devices

All INSTRUMENT, COMPRESSION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.