Blue Ortho recalls Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthrop

Recalled February 19, 2020 · FDA recall Z-1149-2020 · Blue Ortho

Hazard

The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded). · FDA Class II

Units

7 units

Sold at

AZ, CA, FL, TN Foreign: Italy

Description

The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

Product

Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

Manufacturer(s)

Blue Ortho

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →