INBONERecalls & reported problems across all models
Wright Medical Technology, Inc. · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 365
- Deaths reported
- 0
- Injuries reported
- 334
- Recalls
- 4
We found 56 models of INBONE by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 365 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2021 and Jul 16, 2026 — classified as 334 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (91 reports).
4 FDA recall records name at least one of these models by its device identifier.
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
INBONE 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.
- Sep 30, 2022Terminated
The tibial tray lock detail is oversized (larger than specification).
Z-0140-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 30, 2022Terminated
The tibial tray lock detail is oversized (larger than specification).
Z-0139-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Nov 4, 2021Terminated
The package contents and package labeling do not match.
Z-0316-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Nov 4, 2021Terminated
The package contents and package labeling do not match.
Z-0315-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported INBONE problems
Device problems
- Adverse Event Without Identified Device or Use Problem178
- Osseointegration Problem91
- Migration45
- Insufficient Device Problem Information39
- Loss of Osseointegration23
- Detachment of Device or Device Component10
- Fracture10
- Break9
Patient problems
- Inadequate Osseointegration116
- Unspecified Infection90
- Implant Pain70
- Insufficient Information52
- Cyst(s)48
- Pain38
- Limb Fracture27
- No Clinical Signs, Symptoms or Conditions27
INBONE models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INBONE 200252903PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall3 reports
- INBONE 220222210EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall3 reports
- INBONE 200252904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- INBONE 220223214EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- INBONE 200347901PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER46 reports
- INBONE 220220902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER36 reports
- INBONE 200010901PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER28 reports
- INBONE 220220903PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER26 reports
- INBONE 200009901PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER25 reports
- INBONE 200010902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER24 reports
- INBONE 200009902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER22 reports
- INBONE 200011901PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER15 reports
- INBONE 220220904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- INBONE 200011902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- INBONE 220222903PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- INBONE 200011904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- INBONE 200222904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- INBONE 220220901PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- INBONE 220252904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- INBONE 220224312EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- INBONE 220252902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- INBONE 220252903PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- INBONE 220252905PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- INBONE 220223208EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- INBONE 200010904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INBONE 220222905PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INBONE 220222206EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INBONE 200347902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INBONE 200222903PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 220222902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 220222904PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 220223210EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 220224310EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 220224314EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 200364002ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INBONE IB200031ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INBONE IB203208PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INBONE 200220903PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 200222902PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 200222905PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 200252905PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 220220905PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 220223212EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 220223308EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 220224409EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 220225410EPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 200089REAMER1 report
- INBONE 200166ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INBONE 100063102ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INBONE 200329102ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INBONE 200380001WRENCH1 report
- INBONE IB100094ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INBONE IB203210PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE IB204310PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INBONE 200134SBIT, SURGICAL1 report
- INBONE IB200020BIT, SURGICAL1 report
Recent INBONE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 16, 2026Unstable
SUBJECT: (B)(6). UK INFINITY® TOTAL ANKLE SYSTEM STUDY. ON (B)(6) 2018 INSTABILITY IN RIGHT ANKLE WITH ONGOING PAIN VERY POOR BONE QUALITY. LACK OF BONE INTEGRATION INTO PRODENSE GRAFTING IN THE RIGHT ANKLE. STRONG HISTORY OF INFECTION IN KNEE. PATIENT WAS DUE TO BE ADMITTED TO RULE OUT POOR BONE INTEGRATION VERSUS INFECTION IN THE ANKLE, HOWEVER PATIENT DID NOT WISH TO PROCEED.
Patient problems: Joint Laxity; Pain; Unspecified Infection
MAUDE report 25841021 ↗InjuryMay 28, 2026Loss of Osseointegration
THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25319200 ↗InjuryMay 28, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25319198 ↗InjuryMay 28, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25319086 ↗InjuryMay 28, 2026Loss of Osseointegration
THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25319078 ↗MalfunctionApr 17, 2026Component Missing
AS REPORTED: "THIS CASE WAS MISSING THE TALAR PEG DRILL (IB200020) THIS CAUSED SOME ISSUES AS WE NEEDED TO SOURCE ANOTHER 4MM DRILL THAT WE COULD USE TO DRILL THE PEG HOLES. THE DRILL WE USED CAME FROM ANOTHER SET AND DIDN¿T QUITE FIT CAUSING HEAT BUILD UP ON INSPECTION AFTER THE CASE I NOTICED HEAT STRESS MARKS ON THE ADAPTIS TALAR TRIAL, AND THE DRILL BIT HAD BEEN RENDERED BLUNT. THERE WAS NO METAL DEBRIS LEFT IN THE PATIENT. THIS ISSUE CAUSED A SMALL DELAY BUT NEEDED EXTRA IMPACTION OF THE TALUS COMPONENT AS THE DRILL PROBABLY DIDN¿T DO AS GOOD A JOB AS THE REAL DEVICE. THIS PATIENT HAD A 3 TIBIA AND A 3 TALUS. IF WE HAD OPENED THE PREVIOUS SET, WE WOULD HAVE HAD SOME ISSUES WITH THE MISSING POLY IT WAS MORE LUCK THAN JUDGEMENT. I NORMALLY GET A NO STOCK FOR THESE ITEMS BUT ON THIS OCCASION, I HAD NO EMAIL WARNING OF THE STATE OF THE SETS. THE SETS ARE DUE TO BE PICKED UP TODAY CAN THEY BE QUARANTINED AND RECTIFIED BEFORE REDEPLOYMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24907199 ↗InjuryApr 15, 2026Fracture
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED IN 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO IMPLANT FRACTURE IN TALAR COMPONENT/UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Pain
MAUDE report 24889002 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT RECEIVED A CEMENT SPACER.
Patient problems: Insufficient Information
MAUDE report 24735398 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.
Patient problems: Arthritis; Post Operative Wound Infection
MAUDE report 24654551 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.
Patient problems: Arthritis; Post Operative Wound Infection
MAUDE report 24654469 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.
Patient problems: Arthritis; Post Operative Wound Infection
MAUDE report 24653894 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 24544225 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 24544223 ↗InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 24544117 ↗InjuryMar 9, 2026Loss of Osseointegration
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TALAR COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis
MAUDE report 24543941 ↗
Other Wright Medical Technology, Inc. products
- INFINITY51 models · 733 reports · 3 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
- 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.
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