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.
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
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.
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.
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.
Check if you have the TKA Pro v2.1 software installed on Exactech GPS systems used for knee arthroplasty. The catalog reference is L00002.
Reach out to Blue Ortho directly to confirm if your software version is affected and get instructions for updates.
The software displays incorrect navigated values, which could lead to inaccurate surgical planning, but the recall does not specify immediate danger to patients.
Check if you have the TKA Pro v2.1 software installed on Exactech GPS systems for knee arthroplasty, with catalog reference L00002.
Contact Blue Ortho directly to confirm if your software version is affected and get instructions for updates.
We’ve drafted a message you can send Blue Ortho to request your refund or repair — edit it as you like.
Subject: Recall Z-1149-2020 — Blue Ortho Blue Ortho Hello, I own a Blue Ortho that is covered by recall Z-1149-2020 from Blue Ortho. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
