4 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
FDA Recall
Terminated
·Product code OLO·September 22, 2019
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
FDA Enforcement
Class II
·Terminated·Blue Ortho·February 19, 2020
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Instructions For Use document of the GPS Trackers.
FDA Recall
Terminated
·Product code OLO·September 10, 2020