VantageRecalls & reported problems across all models
Exactech, Inc. · 66 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Vantage model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 89
- Recalls
- 2
We found 66 models of Vantage by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2019 and May 27, 2026 — classified as 89 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Break” (26 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
Vantage 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.
- Nov 21, 2023Open, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0587-2024 · Root cause: Packaging change control · names 2 of these models · Recall details · FDA record ↗
- Aug 30, 2021Open, Classified
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Z-0024-2022 · Root cause: Process control · names 39 of these models · Recall details · FDA record ↗
Most reported Vantage problems
Device problems
- Adverse Event Without Identified Device or Use Problem32
- Break26
- Naturally Worn19
- Loosening of Implant Not Related to Bone-Ingrowth16
- Appropriate Device Problem Term/Code Not Available8
- Fracture8
- Insufficient Device Problem Information8
- Migration6
Patient problems
- Failure of Implant34
- Pain32
- No Clinical Signs, Symptoms or Conditions23
- Implant Pain17
- Cyst(s)16
- Insufficient Information13
- Ambulation or Postural Difficulties9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
Vantage models
66 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vantage 350-22-03Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- Vantage 350-22-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- Vantage 350-21-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 reports
- Vantage 350-22-01Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall3 reports
- Vantage 350-22-11Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall3 reports
- Vantage 350-21-01Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-21-03Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-21-13Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-21-22Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-21-23Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-22-12Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-22-23Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-22-43Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-22-44Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall2 reports
- Vantage 350-21-11Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall1 report
- Vantage 350-21-14Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall1 report
- Vantage 350-22-64Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall1 report
- Vantage 350-21-12Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-21Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-24Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-13Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-14Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-21Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-22Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-24Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-41Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-42Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-43Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-44Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-41Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-42Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-61Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-62Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-63Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-21-64Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-62Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-22-63Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Vantage 350-12-03Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer11 reports
- Vantage 351-07-04PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- Vantage 350-11-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer5 reports
- Vantage 351-10-26PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Vantage 350-11-01Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer4 reports
- Vantage 351-90-04TEMPLATE4 reports
- Vantage 351-17-02PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Vantage 350-02-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer3 reports
- Vantage 350-10-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer3 reports
- Vantage 350-11-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Vantage 350-12-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Vantage 350-12-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Vantage 350-01-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Vantage 351-10-13PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Vantage 350-11-03Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 350-12-01Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 350-01-03Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 350-01-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 350-02-04Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 351-93-01IMPACTOR1 report
- Vantage 351-15-22TEMPLATE1 report
- Vantage 350-21-05Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 350-22-25Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 350-10-02Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 report
- Vantage 351-10-08TEMPLATE1 report
- Vantage 03-PML-15-0004PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Vantage 03-PMR-20-0005PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent Vantage adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT DEVELOPED A GANGLION CYST AND BELIEVED THAT THE TIBIAL INSERT WAS DEFECTIVE. AS A RESULT, THE PATIENT UNDERWENT AN ANKLE REVISION APPROXIMATELY, 3 YEARS AND 1 MONTH AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Cyst(s)
MAUDE report 25307555 ↗InjuryMay 7, 2026Migration
AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL ANKLE REPLACEMENT. SUBSEQUENTLY, 9 MONTHS LATER, THE PATIENT'S 3D+ TIBIAL COMPONENT HAS COLLAPSED ANTERIORLY. THE SURGEON PLANS TO REVISE TO COMPETITOR DEVICES.
Patient problems: Insufficient Information
MAUDE report 25110575 ↗InjuryMar 9, 2026Naturally Worn
THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL ANKLE ARTHROPLASTY. THE PATIENT LATER PRESENTED TO THE SURGEON¿S OFFICE WITH PAIN AND POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 24547012 ↗InjuryFeb 2, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND LOOSENING OF THE TIBIAL PLATE. AS A RESULT, THE PATIENT UNDERWENT AN ANKLE REVISION APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Aseptic loosening; Pain
MAUDE report 24234962 ↗InjuryJan 21, 2026Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 225CC SALINE EXPERIENCED RIGHT SIDED DEFLATION POST OPERATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24136076 ↗InjuryDec 29, 2025Migration; Migration
AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, APPROXIMATELY 2 YEARS AND 5 MONTHS POST THE PATIENT'S PREVIOUS LEFT ANKLE REVISION, THE PATIENT DEVELOPED WORSENING CYST FORMATION AND NEW TALAR SUBSIDENCE. THIS RESULTED IN ANOTHER REVISION TO CORRECT THE TALAR SUBSIDENCE, CYST FORMATION AND OSTEOLYSIS WITH A COMPETITOR IMPLANT. THE OUTCOME IS CONSIDERED TO BE RESOLVED.
Patient problems: Cyst(s); Osteolysis
MAUDE report 23906501 ↗InjuryDec 18, 2025Loss of Osseointegration; Migration; Loss of Osseointegration; Migration
IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCE TALAR SUBSIDENCE. FINDINGS SHOWED LOOSENING OF THE TALAR COMPONENT. AS A RESULT, THE PATIENT WAS REVISED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Inadequate Osseointegration
MAUDE report 23840554 ↗MalfunctionNov 7, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING LIFTOFF OF THE TIBIAL PLATE. UPON A FOLLOW-UP APPOINTMENT WITH THE PATIENT THE SURGEON REPORTED "TIBIAL IMPLANT IS ALMOST COMPLETED SEATED NOW. GREAT ROM". NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498988 ↗InjuryNov 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANKLE REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN RESULTING IN A REVISION. THE SURGEON REMOVED THE TIBIAL COMPONENT AND THE INSERT. IT WAS NOTED THAT THERE WAS TIBIAL LOOSENING AND THAT THE TIBIAL COMPONENT WAS NOT SEATING DUE TO SCLEROTIC TIBIAL BONE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 23487987 ↗InjuryAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD THEIR LEFT ANKLE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE TIBIAL CLIP WAS FOUND ON A LATERAL X-RAY TO BE COMING OUT OF THE POLY. THE POLY WAS EXCHANGED WITH A NEW TIBIAL CLIP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS
Patient problems: Insufficient Information
MAUDE report 22801004 ↗InjuryAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A 72 YO MALE PATIENT, WHO HAD THEIR LEFT ANKLE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE TIBIAL CLIP WAS FOUND ON A LATERAL X-RAY TO BE COMING OUT OF THE POLY. THE POLY WAS EXCHANGED WITH A NEW TIBIAL CLIP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.
Patient problems: Insufficient Information
MAUDE report 22800987 ↗InjuryJul 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT INQUIRED ABOUT A 3D PRODUCTS ABILITY TO BE USED FOR REVISION. THEY WERE LOOKING FOR ANY DATA CONCERNING USING THIS NEW PRODUCT AS A REVISION, WHERE IT WAS ATTEMPTED, AND WHO THE SURGEON WAS WHO DID IT. IT WAS INDICATED THE PATIENT HAD A STANDARD ANKLE IMPLANTED A YEAR PRIOR AND IT HAD COME LOOSE. NO FURTHER INFORMATION.
Patient problems: Aseptic loosening; Joint Laxity
MAUDE report 22638110 ↗InjuryJul 14, 2025Structural Problem; Structural Problem
AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP INITIAL LEFT ANKLE REPLACEMENT, THIS 56 Y/O FEMALE PATIENT WAS REVISED DUE THE LOCKING CLIP DISASSOCIATED FROM TIBIAL TRAY. CLIP BROKE IN SITU. SURGEON SWAPPED OUT CLIP & POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO IMAGES OR X-RAYS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22500178 ↗InjuryApr 24, 2025Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ANKLE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A CYST FORMATION, FREQUENT INVERSION EVENTS DUE TO PERSISTENT ANKLE INSTABILITY AND DISCOMFORT WHILE AMBULATING. ENLARGING CYST FORMATION UNDER TIBIA TRAY LEADING TO POTENTIAL SUBSIDENCE. AS A RESULT, APPROXIMATELY 6 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT ANKLE REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Cyst(s); Discomfort; Joint Laxity
MAUDE report 21901994 ↗InjuryFeb 5, 2025Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY 27 MONTHS AFTER A LEFT TOTAL ANKLE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PAIN AND AMBULATION DIFFICULTIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology; Pain
MAUDE report 21312512 ↗
Other Exactech, Inc. products
- Equinoxe305 models · 2,076 reports · 37 recalls
- Optetrak Logic408 models · 3,306 reports · 3 recalls
- Novation184 models · 1,145 reports · 25 recalls
- Optetrak336 models · 1,773 reports · 6 recalls
- Truliant414 models · 1,010 reports · 2 recalls
- Acumatch A Series94 models · 54 reports · 15 recalls
- MCS25 models · 7 reports · 5 recalls
- Alteon135 models · 100 reports · 3 recalls
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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