Optetrak UnicondylarRecalls & reported problems across all models
Exactech, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Optetrak Unicondylar model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 25 models of Optetrak Unicondylar by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2023 and Feb 5, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Optetrak Unicondylar 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.
- Aug 30, 2021Open, Classified
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Z-0020-2022 · Root cause: Process control · names 24 of these models · Recall details · FDA record ↗
Most reported Optetrak Unicondylar problems
Device problems
- Insufficient Device Problem Information2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Naturally Worn1
Patient problems
- Insufficient Information2
- Joint effusion2
- Pain2
- Synovitis2
- Abdominal Pain1
Optetrak Unicondylar models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Optetrak Unicondylar 252-12-03Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall1 report
- Optetrak Unicondylar 252-13-06Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall1 report
- Optetrak Unicondylar 252-12-01Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-12-02Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-12-04Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-12-05Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-12-06Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-13-01Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-13-02Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-13-03Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-13-04Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-13-05Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-22-01Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-22-02Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-22-03Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-22-04Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-22-05Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-22-06Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-23-01Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-23-02Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-23-03Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-23-04Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-23-05Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 252-23-06Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 recall0 reports
- Optetrak Unicondylar 250-01-05Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
Recent Optetrak Unicondylar adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. PATIENT STATED THEY UNDERWENT A KNEE REPLACEMENT SURGERY ON THEIR LEFT KNEE, WHICH FAILED, REQUIRING TOTAL KNEE RESTORATION SURGERY.
Patient problems: Insufficient Information
MAUDE report 21314914 ↗InjuryOct 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 34 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR LOOSENING FEMORAL. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0020-2022.
Patient problems: Abdominal Pain; Joint effusion; Pain; Synovitis
MAUDE report 20569373 ↗InjuryOct 24, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.
Patient problems: Insufficient Information; Joint effusion; Pain; Synovitis
MAUDE report 17996660 ↗
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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