Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Blue Ortho TKA Pro v2.1 software installed on the Exactech Recalled by Blue Ortho Due to The navigated values displayed when using the LPI...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Blue Ortho directly.
Affected Products
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Quantity: 7 units
Why Was This Recalled?
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Where Was This Sold?
This product was distributed to 4 states: AZ, CA, FL, TN
About Blue Ortho
Blue Ortho has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report