Tornier LatitudeRecalls & reported problems across all models
Tornier, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Tornier Latitude model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 7 models of Tornier Latitude by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between May 3, 2021 and Jul 31, 2026 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Tornier Latitude recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 3, 2025Open, Classified
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
Z-1651-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Tornier Latitude problems
Device problems
- Fracture7
- Break4
- Mechanical Jam3
- Material Twisted/Bent2
- Residue After Decontamination1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient2
Tornier Latitude models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tornier Latitude 9030103Orthopedic manual surgical instrument1 recall0 reports
- Tornier Latitude 9030394INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT6 reports
- Tornier Latitude 9030375SCREWDRIVER3 reports
- Tornier Latitude 9030200Guide, surgical, instrument2 reports
- Tornier Latitude 9030280Orthopedic manual surgical instrument1 report
- Tornier Latitude 9030220BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Tornier Latitude 9030155INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1 report
Recent Tornier Latitude adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50104768 ↗MalfunctionMay 13, 2026Fracture
IT WAS REPORTED THAT, THE DISTAL END OF THE 5MM REAMER SEPARATED AFTER THE REAMER WAS REMOVED FROM REAMING THE ULNAR CANAL. SURGEON PROCEEDED WITH THE CASE AND USED THE NEXT SIZED REAMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164944 ↗MalfunctionOct 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE LATITUDE EV KIT WAS USED. WHEN USING 2 OF THE FLEXIBLE REAMERS ON THE KIT THEY SNAPPED/BROKE AND THEREFORE WILL NEED REPLACING ON THE KIT. UPON REAMING OVER THE GUIDE WIRE WHEN REMOVING THE REAMER 1 HAD SNAPPED IN HALF, THE SECOND HAD SNAPPED BUT DID NOT COME APART. BOTH REAMERS WERE REMOVED SUCCESSFULLY INCLUDING LOOSE ITEMS DUE TO THE BALL TIPPED WIRE AND NOTHING WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT, THE REAMERS WERE FINISHED WITH SO NOT NEEDED AGAIN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408221 ↗MalfunctionOct 28, 2025Fracture; Fracture
IT WAS REPORTED THAT THE LATITUDE EV KIT WAS USED. WHEN USING 2 OF THE FLEXIBLE REAMERS ON THE KIT THEY SNAPPED/ BROKE AND THEREFORE WILL NEED REPLACING ON THE KIT. UPON REAMING OVER THE GUIDE WIRE WHEN REMOVING THE REAMER 1 HAD SNAPPED IN HALF, THE SECOND HAD SNAPPED BUT DID NOT COME APART. BOTH REAMERS WERE REMOVED SUCCESSFULLY INCLUDING LOOSE ITEMS DUE TO THE BALL TIPPED WIRE AND NOTHING WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT; THE REAMERS WERE FINISHED WITH SO NOT NEEDED AGAIN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405626 ↗MalfunctionMay 27, 2025Mechanical Jam; Mechanical Jam
DURING PRIMARY RIGHT TOTAL ELBOW REPLACEMENT, SEVERAL ISSUES AROSE REGARDING LATITUDE EV INSTRUMENT MALFUNCTION. 1. DURING INITIAL PREPARATION OF THE ULNAR, THE ULNAR JIG, RIGHT WAS FITTED IN PLACE AS PER THE SURGICAL TECHNIQUE. THE LARGE SIZING HUMERAL SPOOL WAS SLID OVER THE CENTRAL AXEL OF THE JIG, AND THE LARGE BELLSAW WAS THEN PLACED OVER THE SPOOL, IN PREPARATION FOR PROFILING THE PROXIMAL ULNAR. WHEN THE SURGEON ACTIVATED THE DRILL-REAMER POWER TOOL, THE BELL SAW CENTRAL AXEL JAMMED WITHIN THE HOLLOW CENTRAL AXEL OF THE JIG. THE SURGEON WAS UNABLE TO ADVANCE THE BELLSAW, OR REMOVE IT, AS IT APPEARED THAT THE METAL SURFACES HAD JAMMED TOGETHER. THE JIG WAS FULLY LOOSENED, THE BELLSAW DETACHED FROM THE DRILL / REAMER POWER TOOL, AND THE JAMMED CONSTRUCT WAS REMOVED, CAREFULLY, FROM THE ELBOW JOINT. THE BELLSAW WAS THEN ABLE TO BE DETACHED FROM THE JIG. ON INSPECTION, THE INNER HOLLOW TUBE OF THE ULNAR JIG, RIGHT, APPEARED TO HAVE METAL FATIGUE, CAUSING THE CENTRAL AXEL OF THE BELLSAW TO JAM. THE SURGEON DECIDED TO USE THE ULNAR JIG, LEFT, FLIPPED IT OVER, POSITIONED IT IN PLACE, AND COMPLETED THE PROFILING OF THE PROXIMAL ULNAR, TO HIS SATISFACTION. NO FURTHER ISSUES WITH USIN
Patient problems: Insufficient Information
MAUDE report 22086850 ↗MalfunctionMay 27, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent
DURING PRIMARY RIGHT TOTAL ELBOW REPLACEMENT, SEVERAL ISSUES AROSE REGARDING LATITUDE EV INSTRUMENT MALFUNCTION. 1. DURING INITIAL PREPARATION OF THE ULNAR, THE ULNAR JIG, RIGHT WAS FITTED IN PLACE AS PER THE SURGICAL TECHNIQUE. THE LARGE SIZING HUMERAL SPOOL WAS SLID OVER THE CENTRAL AXEL OF THE JIG, AND THE LARGE BELLSAW WAS THEN PLACED OVER THE SPOOL, IN PREPARATION FOR PROFILING THE PROXIMAL ULNAR. WHEN THE SURGEON ACTIVATED THE DRILL-REAMER POWER TOOL, THE BELL SAW CENTRAL AXEL JAMMED WITHIN THE HOLLOW CENTRAL AXEL OF THE JIG. THE SURGEON WAS UNABLE TO ADVANCE THE BELLSAW, OR REMOVE IT, AS IT APPEARED THAT THE METAL SURFACES HAD JAMMED TOGETHER. THE JIG WAS FULLY LOOSENED, THE BELLSAW DETACHED FROM THE DRILL / REAMER POWER TOOL, AND THE JAMMED CONSTRUCT WAS REMOVED, CAREFULLY, FROM THE ELBOW JOINT. THE BELLSAW WAS THEN ABLE TO BE DETACHED FROM THE JIG. ON INSPECTION, THE INNER HOLLOW TUBE OF THE ULNAR JIG, RIGHT, APPEARED TO HAVE METAL FATIGUE, CAUSING THE CENTRAL AXEL OF THE BELLSAW TO JAM. THE SURGEON DECIDED TO USE THE ULNAR JIG, LEFT, FLIPPED IT OVER, POSITIONED IT IN PLACE, AND COMPLETED THE PROFILING OF THE PROXIMAL ULNAR, TO HIS SATISFACTION. NO FURTHER ISSUES WITH USIN
Patient problems: Insufficient Information
MAUDE report 22086760 ↗InjuryMar 1, 2024Break; Fracture; Break; Fracture
DURING A SURGICAL PROCEDURE, THE #5 FLEXIBLE REAMER BROKE WHILE BEING USED ON A PATIENT'S ELBOW. BOTH PIECES OF THE REAMER WERE RETRIEVED, AND AN X-RAY WAS TAKEN, WHICH SHOWED NO ABNORMALITIES. THE ORIGINAL INTENDED PROCEDURE WAS THE REMOVAL OF HARDWARE FROM THE RIGHT ELBOW, INSERTION OF A CEMENT ANTIBIOTIC SPACER, IRRIGATION AND DEBRIDEMENT OF THE RIGHT ELBOW, AND BURSECTOMY OF THE OLECRANON BURSA. THE USER ENCOUNTERED PROBLEMS RELATED TO DEVICE FAILURE AND MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 18822873 ↗MalfunctionFeb 2, 2024
DURING THE SURGICAL PROCEDURE, THE #5 FLEXIBLE REAMER WAS BROKEN WHILE UTILIZING THE INSTRUMENT ON PATIENTS ELBOW. BOTH PIECES OF REAMER OBTAINED. X-RAY OBTAINED. RADIOLOGIST SPOKE TO ATTENDING PHYSICIAN - X-RAY NEGATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629335 ↗MalfunctionJan 30, 2024Residue After Decontamination; Residue After Decontamination
AS REPORTED BY THE CUSTOMER: "WE HAVE NOTICED AN UNKNOWN, WHITE, POWDER-LIKE SUBSTANCE ON THE SURFACE OF CERTAIN LATITUDE INSTRUMENTS. THESE SUBSTANCES SEEM TO APPEAR DURING THE REPROCESSING OF THE INSTRUMENTS IN A VALIDATED AUTOMATIC WASHING PROCESS IN CSSD. THESE SUBSTANCES HAVE BEEN FOUND ON ONLY SOME INSTRUMENTS, NOT ALL OF THEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18610600 ↗MalfunctionMar 1, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OF IN THE SCREW HEAD AND REMAINED IN THE PATIENT. THIS CAUSED A 2 MINUTE DELAY IN SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 13636174 ↗MalfunctionFeb 16, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE ULNAR REAMER GOT STUCK AND WOULDN'T WORK.
Patient problems: Insufficient Information
MAUDE report 13546465 ↗MalfunctionFeb 16, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE ULNAR REAMER GOT STUCK AND WOULDN'T WORK.
Patient problems: Insufficient Information
MAUDE report 13546462 ↗MalfunctionAug 16, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY THE TIP OF THE DRIVER BROKE OFF TRYING TO LOOSEN THE ULNA CAP OFF OF THE LOOSE ULNA COMPONENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12328279 ↗MalfunctionMay 3, 2021Break; Break
IT WAS REPORTED THE DRIVER WAS BEING USED WITH A 10NM TORQUE HANDLE AND THAT THE TIP OF THE DRIVER BROKE OFF IN THE HEAD OF THE SCREW AND WAS COLD WELDED TO THE SCREW HEAD. THE TIP WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT. THE SURGEON PROCEEDED TO FOLD THE TAB OVER WITH THE PUNCH ON THE ULNAR CAP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 11767762 ↗
Other Tornier, Inc. products
- Tornier Perform Reversed Glenoid41 models · 515 reports · 1 recall
- Tornier Perform40 models · 290 reports · 1 recall
- TORNIER PERFORM HUMERAL SYSTEM68 models · 190 reports · 1 recall
- Tornier HRS40 models · 176 reports · 1 recall
- Tornier Perform Reversed Augmented Glenoid8 models · 121 reports · 1 recall
- AEQUALIS FLEX REVIVE24 models · 70 reports · 2 recalls
- Latitude - Elbow35 models · 147 reports
- Latitude EV24 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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