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

Recall date

September 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1149-2020

FDA classification

Class II

Brand / firm

Blue Ortho

Sold / distributed

AZ, CA, FL, TN Foreign: Italy

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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