Blue Ortho TKA Pro v2.1 Software Recall: Incorrect Navigation Data
Blue Ortho recalls TKA Pro v2.1 software for Exactech GPS knee surgery systems due to incorrect navigated values. Affected users should contact Blue Ortho for updates.
Lower-risk recall
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Contact the company
What happened, in plain English
Blue Ortho is recalling TKA Pro v:2.1 software for Exactech GPS knee surgery systems because the navigation data is incorrect. This could lead to inaccurate surgical planning and potentially unsafe procedures. Read more at govinfonow.com/recall/66972-blue-ortho-tka-pro-v2-1-software-recall-incorrect-navigation.
Source Summary by GovInfoNow · govinfonow.com/recall/66972-blue-ortho-tka-pro-v2-1-software-recall-incorrect-navigation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1149-2020
Cite this page
“Blue Ortho TKA Pro v2.1 Software Recall: Incorrect Navigation Data.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66972-blue-ortho-tka-pro-v2-1-software-recall-incorrect-navigation. Based on FDA recall #Z-1149-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1149-2020%22&limit=1).
Why it’s dangerous
The software displays incorrect navigated values during knee surgery due to software inconsistencies. This means the surgeon might receive wrong data about the patient's anatomy, which could lead to improper surgical planning.
Who’s affected
Surgical teams using Blue Ortho TKA Pro v2.1 software with Exactech GPS systems for knee replacements are affected. Surgeons and their teams are most at risk due to potential inaccuracies in surgical navigation.
How to tell if you have this one
Check if you have the TKA Pro v2.1 software installed on Exactech GPS systems used for knee arthroplasty. The catalog reference is L00002.
- Brand
Blue Ortho- Category
Medical device
What to do — step by step
Contact Blue Ortho
Reach out to Blue Ortho directly to confirm if your software version is affected and get instructions for updates.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
FDA distribution: “AZ, CA, FL, TN Foreign: Italy” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Tennessee.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1149-2020 (September 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1149-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.