VALORRecalls & reported problems across all models
Wright Medical Technology, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 25 models of VALOR by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between May 14, 2021 and Mar 25, 2026 — classified as 25 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (12 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 VALOR problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Failure to Align12
- Fracture11
- Break9
- Mechanical Jam4
- Positioning Failure4
- Material Deformation3
- Migration3
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Unspecified Infection20
- Inflammation12
- Nonunion/Delayed-union Bone Fracture12
- Insufficient Information9
- Implant Pain7
- Failure of Implant5
- Bacterial Infection1
VALOR models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VALOR 4150011000Guide, surgical, instrument15 reports
- VALOR 4150011002Guide, surgical, instrument5 reports
- VALOR 4151150075ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- VALOR 4150011004Guide, surgical, instrument3 reports
- VALOR 4151150030ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- VALOR 4151150035ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- VALOR 4151150040ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- VALOR 4151150085ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- VALOR 4151150055ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Valor® 415101015LScrew, fixation, bone2 reports
- Valor® 415101020LScrew, fixation, bone2 reports
- Valor® 415101020RScrew, fixation, bone2 reports
- Valor® 415101120LScrew, fixation, bone2 reports
- VALOR 4151150045ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- VALOR 4151150050ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- VALOR 4151150100ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- VALOR 4151200003ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Valor® 415101030RScrew, fixation, bone1 report
- Valor® 415101115LScrew, fixation, bone1 report
- Valor® 415101125LScrew, fixation, bone1 report
- Valor® 415101125RScrew, fixation, bone1 report
- Valor® 415101130LScrew, fixation, bone1 report
- VALOR 4150006125REAMER1 report
- VALOR 4150011003Guide, surgical, instrument1 report
- VALOR 4150003001DRIVER, PROSTHESIS1 report
Recent VALOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Fracture
VALOR NAIL INSERTED BROKE, NO DELAYS IN CASE, ALL PARTS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690383 ↗MalfunctionNov 12, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT A VALOR TARGETING HANDLE AND GUIDE BECAME STUCK TOGETHER WHILE BEING ASSEMBLED IN THE WAREHOUSE. THE SALES REPRESENTATIVE NOTED THAT THE GUIDE COULD NOT BE DETACHED FROM THE HANDLE AFTER PLACEMENT IN THE INSTRUMENT TRAY. BOTH COMPONENTS WERE BRAND NEW AND HAD NOT BEEN USED IN ANY SURGICAL PROCEDURES. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538683 ↗MalfunctionNov 12, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT A VALOR TARGETING HANDLE AND GUIDE BECAME STUCK TOGETHER WHILE BEING ASSEMBLED IN THE WAREHOUSE. THE SALES REPRESENTATIVE NOTED THAT THE GUIDE COULD NOT BE DETACHED FROM THE HANDLE AFTER PLACEMENT IN THE INSTRUMENT TRAY. BOTH COMPONENTS WERE BRAND NEW AND HAD NOT BEEN USED IN ANY SURGICAL PROCEDURES. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538657 ↗MalfunctionNov 4, 2025Use of Device Problem; Use of Device Problem
VALOR NAIL ALIGNMENT GIG IS OUT OF SPEC/HAS PLAY AND THEREFORE CAUSING SURGICAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462953 ↗MalfunctionNov 4, 2025Use of Device Problem; Use of Device Problem
VALOR NAIL ALIGNMENT GIG IS OUT OF SPEC/HAS PLAY AND THEREFORE CAUSING SURGICAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462714 ↗MalfunctionOct 30, 2025Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT HAD A BROKEN SPRING INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425078 ↗InjuryAug 21, 2025Break; Fracture; Break; Fracture
AS REPORTED: "ORIGINAL SURGERY WAS (B)(6) 2024. AT SOME POINT MONTHS AFTER, THE NAIL BROKE".
Patient problems: Insufficient Information
MAUDE report 22864660 ↗MalfunctionMar 28, 2025Positioning Failure; Failure to Align; Positioning Failure; Failure to Align
"THE VALOR JIG IS FAILING TO ALIGN FOR SCREW PLACEMENT " THE INCIDENT OCCURRED TODAY. SURGERY WAS COMPLETED BUT IT TOOK LONGER & WE HAD TO FREEHAND."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21723988 ↗MalfunctionMar 28, 2025Failure to Align; Failure to Align
"THE VALOR JIG IS FAILING TO ALIGN FOR SCREW PLACEMENT " THE INCIDENT OCCURRED TODAY. SURGERY WAS COMPLETED BUT IT TOOK LONGER & WE HAD TO FREEHAND."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21723946 ↗MalfunctionMar 27, 2025Break; Fracture; Break; Fracture
AS REPORTED: "WHEN SCREWING IN THE CALCANEUS SCREW, THE SCREWDRIVER BROKE OFF AT THE TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713239 ↗MalfunctionMar 27, 2025Material Fragmentation; Damaged Thread; Material Fragmentation; Damaged Thread
IT WAS REPORTED THAT THE THREADS OF THE NAIL, WHICH ATTACH TO THE OUTRIGGER JIG, STRIPPED WHILE BACKING OUT THE NAIL. THIS RESULTED IN A 30-MINUTE SURGICAL DELAY, THOUGH NO ADVERSE CONSEQUENCES WERE REPORTED FOR THE PATIENT. TO COMPLETE THE PROCEDURE, A STERILIZED REMOVAL TOOL WAS USED TO EXTRACT THE NAIL, AND THE IMPLANT WAS DOWNSIZED TO A 250MM VALOR NAIL. THE AFFECTED IMPLANT IS AVAILABLE FOR MANUFACTURER EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708343 ↗InjuryFeb 10, 2025Break; Fracture; Break; Fracture
ITALIAN DISTRIBUTOR WALDNER REPORTED THAT A VALOR NAIL WAS REMOVED IN ABANO ON WEDNESDAY 8TH. THE NAIL BROKE 7 YEARS AFTER IMPLANTATION. THE BREAK POINT CORRESPONDS TO THE HOLE FOR THE SUBTALAR SCREW THAT HAD NOT BEEN PLACED. UNANTICIPATED MEDICAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21342989 ↗MalfunctionDec 4, 2024Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam
AS REPORTED: "THE INTERNAL COMPRESSION SCREW WOULD NOT ENGAGE INTO THE CALC COMPRESSION SCREW AND WOULD NOT BACK OUT OF THE NAIL. THE INTERNAL COMPRESSION SCREW COLD WELDED INSIDE THE NAIL. THE TARGETING GUIDE WAS REMOVED FROM THE NAIL TO REMOVE THE INTERNAL COMPRESSION SCREW BUT WERE UNABLE TO EITHER PROGRESS OR REMOVE THE INTERNAL COMPRESSION SCREW. DEVICE WAS STILL ABLE TO ACHIEVE DESIRED FUSION. WE WERE NOT ABLE TO UTILIZE THE INTERNAL COMPRESSION OF THIS PRODUCT. THE APPOSITION OF THE ANKLE JOINT HAD OBTAINED ADEQUATE FUSION FROM THE JOINT DEBRIDEMENT. THE SURGEON PREFERRED ADDITIONAL FUSION WITH THE INTERNAL COMPRESSION WHICH WE WERE UNABLE TO UTILIZE. THE INTERNAL COMPRESSION SCREW WAS LEFT COLD WELDED IN THE PLANTAR/BOTTOM ASPECT OF THE NAIL." IT WAS ADDITIONALLY REPORTED THAT THERE WAS A 35 MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20848801 ↗MalfunctionNov 25, 2024Failure to Align; Failure to Align
IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE CODE 44180025 DID NOT GUARANTEE THE SCREWS TIGHTENING AS IT WENT OFF WHEN IT WAS TENSIONED AND CODE 4150011000 DID NOT ALLOW THE CENTERING OF THE 2 PROXIMAL HOLES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY FREE-HAND-TECHNIQUE WITH FORCING THE SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20771096 ↗MalfunctionNov 12, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation
AS REPORTED: "WE USED THE VALOR FOR THE FIRST TIME AND HAD DIFFICULTY WITH THE GUIDE JIG. THE CULPRIT WAS THE DAMAGED SPRING INSIDE OF THE NAIL ATTACHMENT. ATTACHMENT TO THE NAIL (LEFT) WAS NOT ALLOWING THE NAIL TO TURN TO THE DIFFERENT POSITIONS TO DRILL THE SCREWS. WE MANAGED TO COMPLETE THE OPERATION BUT ONLY BY REMOVING THE DAMAGED SPRING IN THE DEVICE. WE NOTICED THIS DURING THE SURGERY BECAUSE IT IS ESSENTIAL TO THE OPERATION." THE PROCEDURE WAS DELAYED BY 60 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20666944 ↗
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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