FDA-Device2020-02-19Class II
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Blue Ortho
Hazard
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Sold states
AZ, CA, FL, TN Foreign: Italy
Affected count
7 units
Manufactured in
6 Allee De Bethleem, Gieres, France
Products
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2020Don't want to check this manually?
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