Tornier FlexRecalls & reported problems across all models
Tornier · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 15 models of Tornier Flex by Tornier in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Nov 18, 2025 — classified as 6 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Residue After Decontamination” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Tornier Flex problems
Device problems
- Residue After Decontamination13
- Break7
- Fracture6
- Material Fragmentation3
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Degraded1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information5
- No Known Impact Or Consequence To Patient3
- Limb Fracture2
- Patient Problem/Medical Problem2
- Awareness During Anesthesia1
Tornier Flex models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tornier Flex MWF603SINSTRUMENT, COMPRESSION4 reports
- Tornier Flex MWF113Orthopedic manual surgical instrument3 reports
- Tornier Flex MWF601SINSTRUMENT, COMPRESSION3 reports
- Tornier Flex MWF602SINSTRUMENT, COMPRESSION3 reports
- Tornier Flex MWF500SOrthopedic manual surgical instrument2 reports
- Tornier Flex MWF510SOrthopedic manual surgical instrument2 reports
- Tornier Flex MWF520SOrthopedic manual surgical instrument2 reports
- Tornier Flex MWF604SINSTRUMENT, COMPRESSION2 reports
- Tornier Flex MWF103Orthopedic manual surgical instrument1 report
- Tornier Flex MWF108Orthopedic manual surgical instrument1 report
- Tornier Flex MWF221IMPACTOR1 report
- Tornier Flex MWF605SINSTRUMENT, COMPRESSION1 report
- Tornier Flex MWF612SINSTRUMENT, COMPRESSION1 report
- Tornier Flex MWF615SINSTRUMENT, COMPRESSION1 report
- Tornier Flex MWF621CLAMP1 report
Recent Tornier Flex adverse event reports
The 15 most recent reports across all models, 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 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 23576733 ↗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 INSTRUMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23576246 ↗MalfunctionNov 17, 2025Residue After Decontamination; Residue After Decontamination
UPON INSPECTION OF TRAY AT WAREHOUSE, BLOOD/BONE FOUND INSIDE INSTRUMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23575400 ↗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 ↗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 23468995 ↗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 23465747 ↗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 23465541 ↗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 23465070 ↗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 ↗MalfunctionOct 31, 2025Residue After Decontamination; Residue After Decontamination
UPON INSPECTION OF TRAY AT WAREHOUSE, BLOOD WAS FOUND INSIDE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441362 ↗MalfunctionAug 21, 2025Break; Fracture; Break; Fracture
THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862086 ↗MalfunctionApr 24, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT BROKEN MWF510S INSTRUMENT TRIAL THIS AFTERNOON. THE SCREW PLACEMENT SNAPPED ON EXTRACTION OF THE TRIAL ON THE REVIVE TRIAL STEM.
Patient problems: Insufficient Information
MAUDE report 16799104 ↗
Other Tornier products
- Tornier Flex Shoulder System91 models · 791 reports
- Blueprint Mixed Reality8 models · 0 reports · 9 recalls
- AEQUALIS REVERSED II46 models · 405 reports
- AEQUALIS REVERSED41 models · 258 reports
- FLEX SHOULDER SYSTEM35 models · 194 reports
- Tornier Perform Anatomic Glenoid25 models · 81 reports
- Aequalis Ascend Flex30 models · 79 reports
- AEQUALIS15 models · 56 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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