INFINITYRecalls & reported problems across all models
Wright Medical Technology, Inc. · 51 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one INFINITY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 733
- Deaths reported
- 0
- Injuries reported
- 714
- Recalls
- 3
We found 51 models of INFINITY by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 733 adverse event reports in the FDA's MAUDE database, received between May 26, 2021 and Sep 23, 2026 — classified as 714 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (146 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
INFINITY 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 6, 2024Open, Classified
Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
Z-1477-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Jun 13, 2023Open, Classified
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Z-2105-2023 · Root cause: Process control · Recall details · FDA record ↗
- Jun 2, 2022Open, Classified
The instrument is incorrectly color coded.
Z-1291-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported INFINITY problems
Device problems
- Adverse Event Without Identified Device or Use Problem478
- Osseointegration Problem146
- Loss of Osseointegration49
- Migration47
- Insufficient Device Problem Information40
- Fracture12
- Break10
- Defective Device6
Patient problems
- Inadequate Osseointegration160
- Implant Pain153
- Unspecified Infection144
- Pain89
- Osteolysis80
- Cyst(s)74
- Insufficient Information74
- Loss of Range of Motion66
INFINITY models
51 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INFINITY 33630023PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- INFINITY 33650003PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- INFINITY 33600030PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 reports
- INFINITY 33630024PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER53 reports
- INFINITY 33620254PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- INFINITY 33650013PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER44 reports
- INFINITY 33650014PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER41 reports
- INFINITY 33650004PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER37 reports
- INFINITY 33650005PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER32 reports
- INFINITY 33653206PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER31 reports
- INFINITY 33650002PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER30 reports
- INFINITY 33653306PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER22 reports
- INFINITY 33655407PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER21 reports
- INFINITY™ 33680022PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER20 reports
- INFINITY™ 33680023PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER20 reports
- INFINITY 33654406PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER19 reports
- INFINITY™ 33680024PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER18 reports
- INFINITY 33650015PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- INFINITY 33654307PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER14 reports
- INFINITY 33650001PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER13 reports
- INFINITY 33630025PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- INFINITY™ 33680021PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- INFINITY 33630021PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- INFINITY 33651106PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- INFINITY 33653308PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- INFINITY 33652206PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- INFINITY 33653208PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- INFINITY 33652208PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- INFINITY 33654408PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- INFINITY™ 33680025PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- INFINITY 33655508PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- INFINITY 33654309PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- INFINITY 33655506PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- INFINITY 33655409PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- INFINITY 33654311PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INFINITY 33654410PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- INFINITY 33600025ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INFINITY 33623306TEMPLATE2 reports
- INFINITY 33633208PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33651108PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33652210PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33653212PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33654313PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33654412PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33600021PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY 33622206TEMPLATE1 report
- INFINITY 33610002ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INFINITY™ 33680021PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- INFINITY™ 33680023PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent INFINITY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Study: Stryker ITAR-2.Site: (b)(6).Subject: (b)(6).Painful right total ankle replacement, four and a half years post-implantation with associated ankle pain, burning sensation, and increased numbness dorsally to the great toe.Procedure Related: Yes.Device Related: No.
Patient problems: Neuralgia; Numbness; Pain
MAUDE report 50865171 ↗InjuryAug 18, 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) 2026During 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 50295409 ↗InjuryAug 18, 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 July 2026During 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 50295408 ↗InjuryAug 18, 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) 2026During 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 50295378 ↗InjuryAug 17, 2026Fracture; Loss 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 the tibial and talar components, with associated talar osteolysis (lysis of the talus) and fracture of the talar implant component which was not previously reported to the manufacturer.
Patient problems: Osteolysis
MAUDE report 50274699 ↗InjuryAug 17, 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 the tibial and talar components, with associated talar osteolysis (lysis of the talus) and fracture of the talar implant component which was not previously reported to the manufacturer.
Patient problems: Osteolysis
MAUDE report 50274697 ↗InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
Subject: (b)(6).UK INFINITY Total Ankle System Study.Gutter pain:Increased pain reported around the ankle. Plain x rays show some potential gutter impingement. Spect CT scan ordered.
Patient problems: Joint Impingement; Pain
MAUDE report 50222419 ↗InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
Subject: (b)(6).UK INFINITY Total Ankle System Study.Gutter pain:Increased pain reported around the ankle. Plain x rays show some potential gutter impingement. Spect CT scan ordered.
Patient problems: Joint Impingement; Pain
MAUDE report 50222418 ↗InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
Subject: (b)(6).UK INFINITY Total Ankle System Study.Gutter pain:Increased pain reported around the ankle. Plain x rays show some potential gutter impingement. Spect CT scan ordered.
Patient problems: Joint Impingement; Pain
MAUDE report 50222416 ↗InjuryJul 21, 2026Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. PLAN IS TO REVISE TIBIA (IF NEEDED) AND TALUS FOR CERTAIN.
Patient problems: Insufficient Information
MAUDE report 25897294 ↗InjuryJul 16, 2026Unstable
SUBJECT: (B)(6). UK INFINITY® TOTAL ANKLE SYSTEM STUDY. (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 25841018 ↗InjuryJul 16, 2026Unstable
SUBJECT: (B)(6) UK INFINITY® TOTAL ANKLE SYSTEM STUDY. (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 25841016 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). STUDY: STRYKER ITAR-2 - INFINITY WITH ADAPTIS. PROGRESSIVE PERIPROSTHETIC CYSTS. LARGE TALAR CYST ADJACENT TO TALAR IMPLANT ON THE RIGHT ANKLE. REVISION SURGERY WITH POLYETHYLENE COMPONENT REMOVAL PARFORMED ON (B)(6) 2026.
Patient problems: Cyst(s)
MAUDE report 25810895 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) UK INFINITY TOTAL ANKLE SYSTEM STUDY. DISCOMFORT/TENDERNESS MEDICAL ASPECT OF ANKLE (RIGHT). PATIENT EXPERIENCING DISCOMFORT/TENDERNESS, INFORMED BY HER PHYSIOTHERAPIST THAT IT COULD BE TENDON RELATED. USING CRUTCHES TO MOBILIZE AND FINDING IT UNCOMFORTABLE TO GET UP FROM SITTING. PATIENT DISCUSSING WITH HER CONSULTANT. PROCEDURE RELATED: YES.
Patient problems: Discomfort; Pain
MAUDE report 25746058 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). UK INFINITY TOTAL ANKLE SYSTEM STUDY. DISCOMFORT/TENDERNESS MEDICAL ASPECT OF ANKLE (RIGHT). PATIENT EXPERIENCING DISCOMFORT/TENDERNESS, INFORMED BY HER PHYSIOTHERAPIST THAT IT COULD BE TENDON RELATED. USING CRUTCHES TO MOBILIZE AND FINDING IT UNCOMFORTABLE TO GET UP FROM SITTING. PATIENT DISCUSSING WITH HER CONSULTANT PROCEDURE RELATED: YES.
Patient problems: Discomfort; Pain
MAUDE report 25746048 ↗
Other Wright Medical Technology, Inc. products
- 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
- 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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