ORTHOLOC 3DiRecalls & reported problems across all models
Wright Medical Technology, Inc. · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ORTHOLOC 3Di model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 2
We found 23 models of ORTHOLOC 3Di by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Sep 9, 2021 and Oct 16, 2025 — classified as 20 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (10 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
ORTHOLOC 3Di 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.
- Apr 10, 2023Open, Classified
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Z-1467-2023 · Root cause: Employee error · Recall details · FDA record ↗
- Apr 10, 2023Open, Classified
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Z-1466-2023 · Root cause: Employee error · Recall details · FDA record ↗
Most reported ORTHOLOC 3Di problems
Device problems
- Fracture10
- Break9
- Adverse Event Without Identified Device or Use Problem5
- Material Fragmentation5
- Component Missing3
- Failure to Osseointegrate2
- Device Contaminated During Manufacture or Shipping1
- Device Damaged Prior to Receipt by User1
Patient problems
- Nonunion/Delayed-union Bone Fracture8
- Pain8
- No Clinical Signs, Symptoms or Conditions6
- Granuloma5
- Implant Pain4
- Ambulation or Postural Difficulties3
- Failure of Implant3
- Insufficient Information2
ORTHOLOC 3Di models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ORTHOLOC 3DI 58A220RTPlate, fixation, bone1 recall0 reports
- ORTHOLOC 3DI 58A221RTPlate, fixation, bone1 recall0 reports
- ORTHOLOC 3Di 5820MPX1LPlate, fixation, bone3 reports
- ORTHOLOC 3Di 59250095DRIVER, PROSTHESIS3 reports
- ORTHOLOC 3Di 58803514Screw, fixation, bone2 reports
- ORTHOLOC 3Di 58803520PLATE, FIXATION, BONE2 reports
- ORTHOLOC 3Di 587111RTPLATE, FIXATION, BONE2 reports
- ORTHOLOC 3Di 58803516Screw, fixation, bone1 report
- ORTHOLOC 3Di 58802718Screw, fixation, bone1 report
- ORTHOLOC 3Di 58802712PLATE, FIXATION, BONE1 report
- ORTHOLOC 3Di 58803522Screw, fixation, bone1 report
- ORTHOLOC 3Di 58803524PLATE, FIXATION, BONE1 report
- ORTHOLOC 3Di 58803526PLATE, FIXATION, BONE1 report
- ORTHOLOC 3Di 58803528PLATE, FIXATION, BONE1 report
- ORTHOLOC 3Di 59225536Screw, fixation, bone1 report
- ORTHOLOC 3Di 59225545Screw, fixation, bone1 report
- ORTHOLOC 3Di 59225538PLATE, FIXATION, BONE1 report
- ORTHOLOC 3Di 58130008PLATE, FIXATION, BONE1 report
- ORTHOLOC 3Di 5888701LScrew, fixation, bone1 report
- ORTHOLOC 3DI 52020304Plate, fixation, bone1 report
- ORTHOLOC 3Di 5820MPX1RPlate, fixation, bone1 report
- ORTHOLOC 3DI 59206020Plate, fixation, bone1 report
- ORTHOLOC 3DI 58A02712Screw, fixation, bone1 report
Recent ORTHOLOC 3Di adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ORTHOLOC CROSSCHECK PLATE BROKE SOMETIME AFTER THE INITIAL SURGERY WAS COMPLETED RESULTING IN A NON-UNION. THE PATIENT WAS BROUGHT BACK, AND THE SURGEON HAD TO REMOVE THE PLATE AND REPLACED IT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 23318723 ↗InjuryMar 11, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A REVISION SURGERY IS NEEDED DUE TO TALUS COMPONENT SCREWS¿ BREAKAGE. THE EXISTING TIBIA COMPONENT WILL REMAIN IN SITU.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 21577592 ↗InjuryMar 11, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A REVISION SURGERY IS NEEDED DUE TO TALUS COMPONENT SCREWS¿ BREAKAGE. THE EXISTING TIBIA COMPONENT WILL REMAIN IN SITU.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 21577585 ↗InjuryMar 11, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A REVISION SURGERY IS NEEDED DUE TO TALUS COMPONENT SCREWS¿ BREAKAGE. THE EXISTING TIBIA COMPONENT WILL REMAIN IN SITU.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 21577581 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION. ALL IMPLANTS WERE REMOVED, WITH NONE FOUND TO BE BROKEN. THE LOT NUMBERS ARE UNAVAILABLE, AND THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21351332 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION. ALL IMPLANTS WERE REMOVED, WITH NONE FOUND TO BE BROKEN. THE LOT NUMBERS ARE UNAVAILABLE, AND THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21351289 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION. ALL IMPLANTS WERE REMOVED, WITH NONE FOUND TO BE BROKEN. THE LOT NUMBERS ARE UNAVAILABLE, AND THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21351288 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION. ALL IMPLANTS WERE REMOVED, WITH NONE FOUND TO BE BROKEN. THE LOT NUMBERS ARE UNAVAILABLE, AND THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21351285 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION. ALL IMPLANTS WERE REMOVED, WITH NONE FOUND TO BE BROKEN. THE LOT NUMBERS ARE UNAVAILABLE, AND THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21351281 ↗MalfunctionSep 5, 2024Positioning Failure; Positioning Failure
AS REPORTED BY SALES AGENT: "SURGEON PUT PLATE ON AND FIXED WITH ONE SCREW DISTALLY. WENT TO PUT SECOND LOCKING SCREW IN AND SAID SCREW WOULDN¿T LOCK IN. TRIED SEVERAL METHODS TO LOCK IN BUT SURGEON BELIEVES THREADS ON PLATES FAULTY. REMOVED PLATE AND SWAPPED TO STANDARD ORTHOLOC MTP FUSION PLATE. NO FURTHER ISSUES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153766 ↗MalfunctionJul 19, 2024Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing
AS REPORTED: "WHEN WE OPENED UP THE SET IN THEATRE THERE WERE 2X RIGHT MTP CROSSCHECK PLATES (5820MPX1R) AND NO LEFT SIDE (5820MPX1L). THERE WAS A RIGHT SIDED PLATE IN WHERE THE LEFT SHOULD BE. THE PATIENT WE WERE DOING WAS A LEFT. LUCKILY WE WERE ABLE TO BAIL OUT TO A STANDARD ORTHOLOC MTP PLATE. THIS HOWEVER WAS NOT THE SURGEONS PRIMARY PLAN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19780238 ↗InjurySep 29, 2023Break; Fracture; Break; Fracture
A PATIENT UNDERWENT SURGERY DURING WHICH A SMALL BONES STRAIGHT PLATE (52020304) WAS IMPLANTED. SUBSEQUENTLY, THE PLATE BROKE, AS CONFIRMED BY AN IN-CLINIC X-RAY. THE PATIENT APPROACHED THE PHYSICIAN REGARDING A POTENTIAL ISSUE WITH THE PRODUCT, AND THE PHYSICIAN SAW THE PATIENT FOR FURTHER EVALUATION. THE PHYSICIAN BELIEVES THE PATIENT WAS COMPLIANT WITH MOBILIZATION INSTRUCTIONS. THE PATIENT NOTICED THE EVENT DUE TO FOOT PAIN AND SOUGHT AN X-RAY, BUT THE EXACT DATE IS UNCERTAIN. THE IMPLANT WAS INITIALLY USED FOR A NON-DISPLACED 5TH METATARSAL BASE FRACTURE (AO CLASSIFICATION). THE EVENT IS CURRENTLY BEING MANAGED WITHOUT A REVISION PROCEDURE, AND THE PATIENT IS USING A BONE STIMULATOR.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 17848642 ↗MalfunctionSep 29, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
"WHEN ITEMS WERE REMOVED FROM THE PACKAGE, THE 2.7 LOCKING SCREW PACKAGING APPEARED DAMAGED. THE OUTSIDE OF THE PACKAGING WAS VERY DIRTY, AND THE PLASTIC INSIDE WAS BROKEN INTO PIECES RESULTING IN DAMAGE TO PRODUCT AND AN ITEM THAT WAS NO LONGER STERILE AS WELL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17848109 ↗InjuryJun 5, 2023Material Fragmentation; Material Fragmentation
THE ORTHOLOC SYSTEM, COMPOSED OF PLATES AND SCREWS, USED FOR ARTHRODESIS OF THE FIRST RAY OF THE FOOT FOR HALLUX RIGIDUS, RELEASED A METAL FRAGMENT WHICH CAUSED A FOREIGN BODY GRANULOMA IN THE SOFT TISSUE. THIS WAS NOTICED POST-OP ON X-RAY DUE TO PRESENCE OF PAIN. SURGERY WAS NECESSARY TO REMOVE THE GRANULOMA, THE METAL FRAGMENT WAS IDENTIFIED INSIDE IT.
Patient problems: Granuloma; Pain
MAUDE report 17060002 ↗InjuryJun 5, 2023Material Fragmentation; Material Fragmentation
THE ORTHOLOC SYSTEM, COMPOSED OF PLATES AND SCREWS, USED FOR ARTHRODESIS OF THE FIRST RAY OF THE FOOT FOR HALLUX RIGIDUS, RELEASED A METAL FRAGMENT WHICH CAUSED A FOREIGN BODY GRANULOMA IN THE SOFT TISSUE. THIS WAS NOTICED POST-OP ON X-RAY DUE TO PRESENCE OF PAIN. SURGERY WAS NECESSARY TO REMOVE THE GRANULOMA, THE METAL FRAGMENT WAS IDENTIFIED INSIDE IT.
Patient problems: Granuloma; Pain
MAUDE report 17058766 ↗
Other Wright Medical Technology, Inc. products
- INFINITY51 models · 733 reports · 3 recalls
- INBONE56 models · 365 reports · 4 recalls
- INFINITY ADAPTIS8 models · 219 reports
- INFINITY BIOFOAM 3D5 models · 118 reports
- INFINITY EVERLAST20 models · 111 reports
- EVOLVE14 models · 28 reports · 1 recall
- SWANSON12 models · 17 reports · 1 recall
- FUSEFORCE8 models · 59 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.
How reports and recalls are matched · Editorial policy · Report an error on this page