DART-FIRERecalls & reported problems across all models
Wright Medical Technology, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 11 models of DART-FIRE by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2021 and Jun 12, 2024 — classified as 10 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (7 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 DART-FIRE problems
Device problems
- Failure to Advance7
- Difficult to Advance5
- Positioning Failure5
- Migration4
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Bone Fracture(s)6
- Failure of Implant4
- Hypersensitivity/Allergic reaction2
- Ambulation or Postural Difficulties1
- Cramp(s) /Muscle Spasm(s)1
- Diarrhea1
- Erythema1
DART-FIRE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DART-FIRE D1N20014SScrew, fixation, bone7 reports
- DART-FIRE D1N30016SScrew, fixation, bone2 reports
- DART-FIRE D1N30018SScrew, fixation, bone2 reports
- DART-FIRE D1N20016SScrew, fixation, bone2 reports
- DART-FIRE D1N30014SScrew, fixation, bone1 report
- DART-FIRE D1N25012SScrew, fixation, bone1 report
- DART-FIRE D1N35030SScrew, fixation, bone1 report
- DART-FIRE D1N40030SScrew, fixation, bone1 report
- DART-FIRE D1N35026SScrew, fixation, bone1 report
- DART-FIRE D1N35018SScrew, fixation, bone1 report
- DART-FIRE D1N35044SScrew, fixation, bone1 report
Recent DART-FIRE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT IS HAVING A REACTION TO THE SCREWS THAT WERE IMPLANTED. THE SCREWS "BOTHER HER" AND STILL HURT. THE PATIENT IS HAVING SENSITIVITY TO TOUCH WHERE THE IMPLANTS ARE LOCATED. THE PATIENT MENTIONED THAT THE SCREWS ARE ALSO LOOSENING AND MAY NEED TO HAVE REVISION SURGERY TO REMOVE THE SCREWS.
Patient problems: Hypersensitivity/Allergic reaction; Implant Pain
MAUDE report 19520961 ↗InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAD A SMALL SCREW SYSTEM IMPLANTED IN THE LEFT FOOT. FOURTH LEFT METATARSAL BONE IN THE TOE, PATIENT ENDED UP WITH A RASH, HAD IMPLANT REMOVED 4 YEARS POST-OP BECAUSE SHE COULD BARELY WALKED. THE PATIENT WAS CONTACTED BY THE FDA REQUESTING THE LOT NUMBER OF THE SCREW 9 YEARS AFTER THE INITIAL SURGERY. PATIENT BELIEVES SHE DEVELOPED METAL TOXICITY.
Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Diarrhea; Erythema; Hypersensitivity/Allergic reaction; Metal Related Pathology
MAUDE report 17750106 ↗MalfunctionDec 2, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DARTFIRE SCREWS AND HAD A VERY DIFFICULT TIME GETTING THEM TO BITE ENOUGH FOR FIXATION. HE ENDED UP BURNING SEVERAL SCREWS AND WAS NOT AT ALL HAPPY WITH THE RESULT. THIS CAUSED A DELAY IN OR TIME AND RESULTED IN A LESS THAN ADEQUATE CORRECTION FOR THE PATIENT. THE PHYSICIAN WAS ABLE TO FINALLY GET TWO SCREWS TO WORK CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15911741 ↗MalfunctionDec 2, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DARTFIRE SCREWS AND HAD A VERY DIFFICULT TIME GETTING THEM TO BITE ENOUGH FOR FIXATION. HE ENDED UP BURNING SEVERAL SCREWS AND WAS NOT AT ALL HAPPY WITH THE RESULT. THIS CAUSED A DELAY IN OR TIME AND RESULTED IN A LESS THAN ADEQUATE CORRECTION FOR THE PATIENT. THE PHYSICIAN WAS ABLE TO FINALLY GET TWO SCREWS TO WORK CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15911050 ↗MalfunctionDec 2, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DARTFIRE SCREWS AND HAD A VERY DIFFICULT TIME GETTING THEM TO BITE ENOUGH FOR FIXATION. HE ENDED UP BURNING SEVERAL SCREWS AND WAS NOT AT ALL HAPPY WITH THE RESULT. THIS CAUSED A DELAY IN OR TIME AND RESULTED IN A LESS THAN ADEQUATE CORRECTION FOR THE PATIENT. THE PHYSICIAN WAS ABLE TO FINALLY GET TWO SCREWS TO WORK CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15910235 ↗MalfunctionDec 2, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DARTFIRE SCREWS AND HAD A VERY DIFFICULT TIME GETTING THEM TO BITE ENOUGH FOR FIXATION. HE ENDED UP BURNING SEVERAL SCREWS AND WAS NOT AT ALL HAPPY WITH THE RESULT. THIS CAUSED A DELAY IN OR TIME AND RESULTED IN A LESS THAN ADEQUATE CORRECTION FOR THE PATIENT. THE PHYSICIAN WAS ABLE TO FINALLY GET TWO SCREWS TO WORK CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15909676 ↗MalfunctionDec 2, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DARTFIRE SCREWS AND HAD A VERY DIFFICULT TIME GETTING THEM TO BITE ENOUGH FOR FIXATION. HE ENDED UP BURNING SEVERAL SCREWS AND WAS NOT AT ALL HAPPY WITH THE RESULT. THIS CAUSED A DELAY IN OR TIME AND RESULTED IN A LESS THAN ADEQUATE CORRECTION FOR THE PATIENT. THE PHYSICIAN WAS ABLE TO FINALLY GET TWO SCREWS TO WORK CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15909107 ↗MalfunctionJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. THERE WAS A DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12038084 ↗InjuryJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. DURING INSERTION OF THE SCREW THE BONE CRACKED.
Patient problems: Bone Fracture(s)
MAUDE report 12038083 ↗InjuryJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. DURING INSERTION OF THE SCREW THE BONE CRACKED.
Patient problems: Bone Fracture(s)
MAUDE report 12038082 ↗InjuryJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. DURING INSERTION OF THE SCREW THE BONE CRACKED.
Patient problems: Bone Fracture(s)
MAUDE report 12038081 ↗InjuryJun 21, 2021Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038060 ↗MalfunctionJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. THERE WAS A DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12038059 ↗InjuryJun 21, 2021Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038058 ↗MalfunctionJun 21, 2021Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. SCREW IS BACKING OUT POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 12038046 ↗
Other Wright Medical Technology, Inc. products
- INFINITY51 models · 733 reports · 3 recalls
- INBONE56 models · 365 reports · 4 recalls
- INFINITY ADAPTIS8 models · 219 reports
- ORTHOLOC 3Di23 models · 28 reports · 2 recalls
- INFINITY BIOFOAM 3D5 models · 118 reports
- INFINITY EVERLAST20 models · 111 reports
- EVOLVE14 models · 28 reports · 1 recall
- SWANSON12 models · 17 reports · 1 recall
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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